4,433 Quality Systems jobs in India

Quality Management Systems

Bengaluru, Karnataka TE Connectivity

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Job Description

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Job Overview

TE Connectivity's Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.

RESPONSBILITIES

Works with Research and Design teams to implements standards, methods and procedures for inspecting, technical quality assurance and control systems and activities, testing and evaluating the precision, accuracy and reliability of company products. Use standard procedures (ISO 9001, AS 9100, IATF16949, ISO TS 22163, ISO 13485, ISO 17025) and other relevant regulations.

•Ensures compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for design and production.
•Participates in the reviewing of engineering designs to contribute quality requirements and considerations.
•Performs evaluation and audits of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
•Identifies risk and evaluates deficiencies and works with internal departments/business units to appropriately remedy them, evaluating the results of corrective actions. 
•Facilitates internal training on quality assurance requirements, processes, and procedures.
•Support Management Review process, organize meetings, ensure compliance with requirements
•Maintain records according to TE Corporate Records Retention Policy and customer requirements
•Manage site procedures, specifications and other controlled documents ensuring compliance with regulatory, TE and local procedures and requirements (including management of document change control and all elements of the document lifecycle)
•Support Quality and Company objectives and goals

DESIRED SKILLS

Bachelor’s degree in Engineering, Quality Management/related field or 8 years Quality processes and systems experience. Experience with product and process design and manufacturing, electro-mechanical devices or sensors would be preferred. 
Highly organized and able to clearly communicate requirements, and partner with stakeholders to implement and/or improve processes

Solid understanding of the following bodies of knowledge:
-ISO 9001
-AS 9100
-IATF16949
-ISO TS 22163
-ISO 13485
-ISO 17025


Understanding of the key quality terms, definition, facts, methods, and principles
Ability to evaluate proposed ideas, solutions, corrections compared to specifications
Advanced computer experience with writing and editing documentation
Read and understand descriptions, reports, regulations, instructions, technical documents, etc.
Ability to breakdown and analyze information and recognize their relationship to one another
Ability to communicate complex issues and solutions to cross-functional teams verbally and in writing

Competencies

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
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Platform Engineer - Quality Management Systems

Bengaluru, Karnataka Astellas Pharma

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Job Description

**Job Title - Platform Engineer - Quality Management Systems**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
**Astellas' Global Capability Centers - Overview**
Astellas' Global Capability Centers (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
This position is based in Bengaluru and will require some on-site work.
**Purpose and Scope:**
As a Quality Platforms Engineer of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components - Digital Capability and Digital Execution. Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement.
A Platform Engineer focuses on the development, deployment, and integration of quality management platforms such as TrackWise Digital that support our business processes and operations. This role involves a blend of technical expertise, business acumen, and a deep understanding of quality systems. The goal is to ensure these platforms are optimized to support business goals, enhance efficiency, and drive growth.
You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field.
**Essential Job Responsibilities:**
+ Platform Development and Configuration: Design, develop, and configure business platforms to meet the specific needs of our organization. This could involve programming, configuring settings, and integrating various software solutions.
+ System Integration: Ensure seamless integration between different business platforms and systems (e.g., TrackWise integrating with Data Lakes, Databricks, MuleSoft and ERP systems) to enhance data flow and business processes.
+ Performance Monitoring and Optimization: Regularly monitor the performance of business platforms, identify bottlenecks, and implement optimizations to improve efficiency and user experience.
+ User Support and Training: Provide technical support to platform users, resolve issues, and conduct training sessions to ensure users can effectively utilize the platforms.
+ Initiative Execution: Actively participate in and contribute to various initiatives, applying your specialized skills to achieve the objectives and expected Value. Contribute to the ongoing realization of Value from these enterprise platforms through continuous integration and deployment.
+ Collaboration: Work collaboratively with team members within the subdivision and across other digital and business units.
+ Continuous Learning: Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in a specific area of expertise.
+ Innovation: Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities.
+ Reporting: Regularly report on the progress of the various Value Teams and outcomes to your Capability Lead and team members.
+ Problem-Solving: Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions.
+ Quality Assurance: Ensure the highest quality and consistency in the work delivered.
**Qualifications** **Required**
+ Bachelor's degree in relevant field, e.g., Computer Science, Data Science
+ Significant experience in TrackWise Digital Administration, Salesforce Admin/Developer, Integration, Lightening Experience and Reporting and Analytics
+ Business Process Understanding: Knowledge of Quality management business processes and how Trackwise Digital platform supports these processes
+ Strong analytical and problem-solving skills
+ Ability to work effectively in a team environment
+ Excellent communication skills, both written and verbal
+ Agile and adaptable to changing environments and initiative scopes
+ Demonstrated experience working with business to define Epics/user stories/features, as well as conducting impact analysis
+ Present technical solutions based on the business requirement of the Enterprise Quality Management system.
+ Able to support technical upgrade on quarterly basis by conducting technical impact assessment, addressing any technical issues, support the environment management, support testing, and document changes per the SLC process
+ Manage user account, create roles, and support quarterly user access review request.
+ Support system deliverables and provide technical feedback during internal and external system audits
+ Work closely with the internal privacy and security team to assess Personal Information requests and act according per the privacy laws
+ Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during the technical upgrade
+ Lead without authority and be escalation point for any customer issues
**Preferred**
+ TrackWise Digital Admin Certification, Salesforce,
+ 10 years of demonstrated experience with TrackWise Digital/ Salesforce/Veeva platforms
+ Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery
+ Technical Proficiency: Strong coding skills in relevant tools and technologies, e.g., Apex, Visualforce, SOQL, SOSL, Salesforce APIs, Salesforce Dev Tools, Conga reporting tools highly beneficial.
+ Demonstrated experience in TrackWise Digital Platform administration and configuration
+ Significant experience in developing and configuring TrackWise Digital Platform
**Working Environment**
+ At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
Category PlatformX
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
This advertiser has chosen not to accept applicants from your region.

Platform Engineer – Quality Management Systems

Bengaluru, Karnataka Astellas Pharma Inc.

Posted today

Job Viewed

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Job Description

Responsibilities :
  • Platform Development and Configuration: Design, develop, and configure business platforms to meet the specific needs of our organization. This could involve programming, configuring settings, and integrating various software solutions.
  • System Integration: Ensure seamless integration between different business platforms and systems (e.g., TrackWise integrating with Data Lakes, Databricks, MuleSoft and ERP systems) to enhance data flow and business processes.
  • Performance Monitoring and Optimization: Regularly monitor the performance of business platforms, identify bottlenecks, and implement optimizations to improve efficiency and user experience.
  • User Support and Training: Provide technical support to platform users, resolve issues, and conduct training sessions to ensure users can effectively utilize the platforms.
  • Initiative Execution: Actively participate in and contribute to various initiatives, applying your specialized skills to achieve the objectives and expected Value. Contribute to the ongoing realization of Value from these enterprise platforms through continuous integration and deployment.
  • Collaboration: Work collaboratively with team members within the subdivision and across other digital and business units.
  • Continuous Learning: Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in a specific area of expertise.
  • Innovation: Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities.
  • Reporting: Regularly report on the progress of the various Value Teams and outcomes to your Capability Lead and team members.
  • Problem-Solving: Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions.
  • Quality Assurance: Ensure the highest quality and consistency in the work delivered.
  • Requirements

    Qualifications  Required

  • Bachelor’s degree in relevant field, e.g., Computer Science, Data Science
  • Significant experience in TrackWise Digital Administration, Salesforce Admin/Developer, Integration, Lightening Experience and Reporting and Analytics
  • Business Process Understanding: Knowledge of Quality management business processes and how Trackwise Digital platform supports these processes
  • Strong analytical and problem-solving skills
  • Ability to work effectively in a team environment
  • Excellent communication skills, both written and verbal
  • Agile and adaptable to changing environments and initiative scopes
  • Demonstrated experience working with business to define Epics/user stories/features, as well as conducting impact analysis
  • Present technical solutions based on the business requirement of the Enterprise Quality Management system.
  • Able to support technical upgrade on quarterly basis by conducting technical impact assessment, addressing any technical issues, support the environment management, support testing, and document changes per the SLC process
  • Manage user account, create roles, and support quarterly user access review request.
  • Support system deliverables and provide technical feedback during internal and external system audits
  • Work closely with the internal privacy and security team to assess Personal Information requests and act according per the privacy laws
  • Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during the technical upgrade
  • Lead without authority and be escalation point for any customer issues
  • Preferred

  • TrackWise Digital Admin Certification, Salesforce,
  • 10 years of demonstrated experience with TrackWise Digital/ Salesforce/Veeva platforms
  • Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery
  • Technical Proficiency: Strong coding skills in relevant tools and technologies, e.g., Apex, Visualforce, SOQL, SOSL, Salesforce APIs, Salesforce Dev Tools, Conga reporting tools highly beneficial.
  • Demonstrated experience in TrackWise Digital Platform administration and configuration
  • Significant experience in developing and configuring TrackWise Digital Platform
  • Working Environment

  • At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
  • This advertiser has chosen not to accept applicants from your region.

    Quality Systems Specialist-Mumbai.

    Medtronic

    Posted today

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    Job Description

    About the job

    At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

    Our Purpose

    For our Service Operations Supplier Quality team, we are looking for a new team member to strengthen our team. This role will support the organization with day-to-day requirements related to supplier Management. This role will act as first level support for stakeholders and commercial areas involved in the acquisition of new suppliers to support the company operation.

    A Day in the Life

    Responsibilities may include the following and other duties may be assigned:

    · Supplier Performance & Relationship Management:

     oServe as subject matter expert for supplier Management process.

     oSupport users with supplier selection, evaluation and segmentation as per Medtronic supplier management procedures and own and maintain the related required supplier files in the document management system.

     oOwn and maintain Approved Supplier List (ASL) in the document management system.

     oProvide constant updates to the leaders, stakeholders or partners responsible for the supplier approval.

     oPrepare, update and monitor audit / performance evaluation schedules for supplier management process.

     oInvestigate poor supplier performance ratings to identify causes and works with the supplier to implement improvements.

     oAbility to effectively identify root cause and coordinate with supplier to ensure corrective & preventive actions through the (Supplier) CAPA process.

     oProvide guidance for supplier change requests, including communication, project management via document management system and regular reporting.

     oProvide analytical support for key metrics and periodic reporting to update internal stakeholders on the status of supplier management (i.e. # of new suppliers, # of supplier changes, # of SCAPA, etc.).

     oManages relationship with external suppliers to effectively represent Medtronic to the supplier, and appropriately represent the supplier to Medtronic, deliver best value and provide competitive advantage.

     oTrain and mentor any supplier if needed.

     oEnsures supplier meets obligations agreed by contract.

    · Quality Systems/Standards:

    oEnsure personal understanding of all quality policy/system items that are personally applicable.Follow all work/quality procedures to ensure quality system compliance and high-quality work.

    · Compliance:

    oOperate within compliant quality system environments.

    oParticipate and support internal / external Supplier and Quality System Audits in in the regions supported.

    · Continuous Improvement:

    oBe a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, compliance and reduce complexity of processes as required.

    · Systems and Tools :

    oLeverages the business specific tools and systems used throughout Operations at Medtronic for optimal decision-making.

    oUses ERP system (SAP) to conduct normal duties, generate metrics.

    oDemonstrates proficiency in applicable software tools such as MS Excel and Business object.

    · Commercial Agreements:

    oSupports drafting and execution of pertinent written agreements/documents for ongoing requirements, such as purchase orders, and Memoranda of Agreement etc.

    oUnderstands the implications of different types of commercial agreements. Chooses the appropriate agreement for the circumstances.

    Must Have: Minimum Requirements

  • Bachelor’s degree required.
  • Minimum of 2 years of relevant experience in Engineering and/or Quality experience in the medical industry or related field, or advanced degree with 0 years of experience.
  • You are a dynamic team player and can work effectively and proactively on cross functional teams.
  • You are a good communicator and fluent in English, both verbal and written.
  • Evening shift.
  • Nice to Have

    ·Certified Quality Auditor certification.

    ·Previous experience supporting quality system audits.

    ·Strong technical writing and documentation review skills.

    ·Strong critical thinking and analytical skills.

    ·Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk).

    ·Good understanding of the Medical Device Regulations and the Food and Drugs Acts as pertinent to the position.

    ·Working knowledge of ISO 13485, and Medical Devices regulations/guidance on the Control of Products and Services obtained from Suppliers

    ·Good understanding of FDA regulations for Medical Devices and Drugs regarding Complaint Handling/Mandatory Medical Devices Problem Reporting, Adverse Events reporting and Recalls (basic understanding of International regulations).

    ·Certified Quality Engineer, Reliability Engineer, or equivalent desired.

    ·Influence management skills; ability to work constructively across all functions of the organization and build relationships

    ·Experience writing and reviewing of technical documentation.

    This advertiser has chosen not to accept applicants from your region.

    Manager - Digital Quality Systems & Data Governance

    Dera Bassi, Punjab Panacea Biotec

    Posted 3 days ago

    Job Viewed

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    Job Description

    This role will evolve from overseeing the implementation of our Laboratory Information Management System (LIMS) and its integration with Quality Management Systems (QMS) and NetSuite ERP, into a long-term system owner and custodian of digital quality excellence. The role will be pivotal in managing the lifecycle of quality systems, ensuring regulatory compliance, promoting adoption, and driving ongoing digital transformation across quality and lab operations.


    We are seeking a highly motivated tech-savvy QA Specialist with expertise in software and digital systems implementation to join our biopharmaceutical manufacturing facility. This role is pivotal in driving digitalization across Quality Control (QC), Production, and QA operations , ensuring seamless data collection, validation, software adoption , and system compliance. The ideal candidate will work cross-functionally with manufacturing, QA/QC, IT, and Regulatory Affairs to enhance efficiency, productivity , and regulatory readiness .


    Reports to: Head – Quality Assurance

    Key Responsibilities

    1. Software Implementation & Validation:

    • Lead the selection, design, implementation, validation, deployment, maintenance and support of electronic systems across QA, QC, Production, and Supply Chain (e.g., LIMS, MES, eBMR, ERP, CDS, QMS) across multiple sites.
    • Partner with Production, Engineering, Quality Control (QC), Quality Assurance (QA), IT, and Operations to define user requirements, workflows, and system improvements.
    • Ensure all systems comply with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and Data Integrity standards.
    • Draft and review documentation such as URS , FDS , IQ/OQ/PQ protocols , traceability matrices , and automated validation reports .

    2. Quality Oversight & Data Integrity:

    • Oversee digital workflows , ensuring they align with SOPs, batch records , and regulatory expectations .
    • Monitor and audit electronic data for integrity, traceability, and compliance .
    • Support CAPAs and investigations related to software failures or deviations involving digital systems.

    3. Digital Process Improvement and Analytics:

    • Partner with operations and IT teams to identify process automation opportunities , improve data flow and transparency , and lead adoption of AR/VR across different application areas.
    • Creation of unified data lakes or warehouses
    • Lead the development of dashboards, analytics tools , and AI/ML-based insights for predictive quality and productivity.
    • Identification and adoption of IoT including sensors, etc. for data collection and processing of information to improve uptimes

    4. GXP Training & Change Management:

    • Lead training initiatives to support software onboarding and proper usage by shop-floor staff.
    • Act as a digital transformation champion , promoting system adoption and reducing manual dependencies.

    5. Regulatory Interface:

    • Interface with internal Regulatory Affairs to support submissions , inspections, and responses to queries involving computerised systems .
    • Prepare and participate in regulatory audits (USFDA, EMA, WHO, CDSCO, etc.) related to data management and software validation.

    6. Life Cycle Management:

    • Governance of Master Data Management
    • Manage configuration changes, upgrades, and enhancement projects in GxP applications
    • Manage software vendor relationships, renewals, SLAs, and support issue escalations.
    • Optimize licensing and plan budget for system operations and enhancements.

    Qualifications & Experience

    • Bachelor’s/Master’s in Life Sciences, Computer Science, or Pharmaceutical Sciences.
    • 10+ years industry experience in a GMP-regulated (Pharma/Biotech) environment with experience in LIMS/QMS/ERP systems.
    • Strong understanding of GxP, 21 CFR Part 11, Annex 11, and CSV principles.
    • Proven record of system ownership post-implementation and cross-functional leadership.

    Skills & Competencies

    • Mastery of digital quality systems and data governance.
    • Strong project and change management skills.
    • Excellent communication, leadership, and collaboration abilities.
    • Strong knowledge of laboratory workflows and QC operations
    • Strong analytical skills and comfort with reporting and dashboards.
    This advertiser has chosen not to accept applicants from your region.

    Manager - Digital Quality Systems & Data Governance

    Punjab, Punjab Panacea Biotec

    Posted 3 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    This role will evolve from overseeing the implementation of our Laboratory Information Management System (LIMS) and its integration with Quality Management Systems (QMS) and NetSuite ERP, into a long-term system owner and custodian of digital quality excellence. The role will be pivotal in managing the lifecycle of quality systems, ensuring regulatory compliance, promoting adoption, and driving ongoing digital transformation across quality and lab operations.

    We are seeking a highly motivated tech-savvy QA Specialist with expertise in software and digital systems implementation to join our biopharmaceutical manufacturing facility. This role is pivotal in driving digitalization across Quality Control (QC), Production, and QA operations , ensuring seamless data collection, validation, software adoption , and system compliance. The ideal candidate will work cross-functionally with manufacturing, QA/QC, IT, and Regulatory Affairs to enhance efficiency, productivity , and regulatory readiness .

    Reports to: Head – Quality Assurance
    Key Responsibilities
    1. Software Implementation & Validation:
    Lead the selection, design, implementation, validation, deployment, maintenance and support of electronic systems across QA, QC, Production, and Supply Chain (e.g., LIMS, MES, eBMR, ERP, CDS, QMS) across multiple sites.
    Partner with Production, Engineering, Quality Control (QC), Quality Assurance (QA), IT, and Operations to define user requirements, workflows, and system improvements.
    Ensure all systems comply with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and Data Integrity standards.
    Draft and review documentation such as URS , FDS , IQ/OQ/PQ protocols , traceability matrices , and automated validation reports .
    2. Quality Oversight & Data Integrity:
    Oversee digital workflows , ensuring they align with SOPs, batch records , and regulatory expectations .
    Monitor and audit electronic data for integrity, traceability, and compliance .
    Support CAPAs and investigations related to software failures or deviations involving digital systems.
    3. Digital Process Improvement and Analytics:
    Partner with operations and IT teams to identify process automation opportunities , improve data flow and transparency , and lead adoption of AR/VR across different application areas.
    Creation of unified data lakes or warehouses
    Lead the development of dashboards, analytics tools , and AI/ML-based insights for predictive quality and productivity.
    Identification and adoption of IoT including sensors, etc. for data collection and processing of information to improve uptimes
    4. GXP Training & Change Management:
    Lead training initiatives to support software onboarding and proper usage by shop-floor staff.
    Act as a digital transformation champion , promoting system adoption and reducing manual dependencies.
    5. Regulatory Interface:
    Interface with internal Regulatory Affairs to support submissions , inspections, and responses to queries involving computerised systems .
    Prepare and participate in regulatory audits (USFDA, EMA, WHO, CDSCO, etc.) related to data management and software validation.
    6. Life Cycle Management:
    Governance of Master Data Management
    Manage configuration changes, upgrades, and enhancement projects in GxP applications
    Manage software vendor relationships, renewals, SLAs, and support issue escalations.
    Optimize licensing and plan budget for system operations and enhancements.
    Qualifications & Experience
    Bachelor’s/Master’s in Life Sciences, Computer Science, or Pharmaceutical Sciences.
    10+ years industry experience in a GMP-regulated (Pharma/Biotech) environment with experience in LIMS/QMS/ERP systems.
    Strong understanding of GxP, 21 CFR Part 11, Annex 11, and CSV principles.
    Proven record of system ownership post-implementation and cross-functional leadership.
    Skills & Competencies
    Mastery of digital quality systems and data governance.
    Strong project and change management skills.
    Excellent communication, leadership, and collaboration abilities.
    Strong knowledge of laboratory workflows and QC operations
    Strong analytical skills and comfort with reporting and dashboards.
    This advertiser has chosen not to accept applicants from your region.

    Manager - Digital Quality Systems & Data Governance

    Dera Bassi, Punjab Panacea Biotec

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    This role will evolve from overseeing the implementation of our Laboratory Information Management System (LIMS) and its integration with Quality Management Systems (QMS) and NetSuite ERP, into a long-term system owner and custodian of digital quality excellence. The role will be pivotal in managing the lifecycle of quality systems, ensuring regulatory compliance, promoting adoption, and driving ongoing digital transformation across quality and lab operations.


    We are seeking a highly motivated tech-savvy QA Specialist with expertise in software and digital systems implementation to join our biopharmaceutical manufacturing facility. This role is pivotal in driving digitalization across Quality Control (QC), Production, and QA operations , ensuring seamless data collection, validation, software adoption , and system compliance. The ideal candidate will work cross-functionally with manufacturing, QA/QC, IT, and Regulatory Affairs to enhance efficiency, productivity , and regulatory readiness .


    Reports to: Head – Quality Assurance

    Key Responsibilities

    1. Software Implementation & Validation:

    • Lead the selection, design, implementation, validation, deployment, maintenance and support of electronic systems across QA, QC, Production, and Supply Chain (e.g., LIMS, MES, eBMR, ERP, CDS, QMS) across multiple sites.
    • Partner with Production, Engineering, Quality Control (QC), Quality Assurance (QA), IT, and Operations to define user requirements, workflows, and system improvements.
    • Ensure all systems comply with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and Data Integrity standards.
    • Draft and review documentation such as URS , FDS , IQ/OQ/PQ protocols , traceability matrices , and automated validation reports .

    2. Quality Oversight & Data Integrity:

    • Oversee digital workflows , ensuring they align with SOPs, batch records , and regulatory expectations .
    • Monitor and audit electronic data for integrity, traceability, and compliance .
    • Support CAPAs and investigations related to software failures or deviations involving digital systems.

    3. Digital Process Improvement and Analytics:

    • Partner with operations and IT teams to identify process automation opportunities , improve data flow and transparency , and lead adoption of AR/VR across different application areas.
    • Creation of unified data lakes or warehouses
    • Lead the development of dashboards, analytics tools , and AI/ML-based insights for predictive quality and productivity.
    • Identification and adoption of IoT including sensors, etc. for data collection and processing of information to improve uptimes

    4. GXP Training & Change Management:

    • Lead training initiatives to support software onboarding and proper usage by shop-floor staff.
    • Act as a digital transformation champion , promoting system adoption and reducing manual dependencies.

    5. Regulatory Interface:

    • Interface with internal Regulatory Affairs to support submissions , inspections, and responses to queries involving computerised systems .
    • Prepare and participate in regulatory audits (USFDA, EMA, WHO, CDSCO, etc.) related to data management and software validation.

    6. Life Cycle Management:

    • Governance of Master Data Management
    • Manage configuration changes, upgrades, and enhancement projects in GxP applications
    • Manage software vendor relationships, renewals, SLAs, and support issue escalations.
    • Optimize licensing and plan budget for system operations and enhancements.

    Qualifications & Experience

    • Bachelor’s/Master’s in Life Sciences, Computer Science, or Pharmaceutical Sciences.
    • 10+ years industry experience in a GMP-regulated (Pharma/Biotech) environment with experience in LIMS/QMS/ERP systems.
    • Strong understanding of GxP, 21 CFR Part 11, Annex 11, and CSV principles.
    • Proven record of system ownership post-implementation and cross-functional leadership.

    Skills & Competencies

    • Mastery of digital quality systems and data governance.
    • Strong project and change management skills.
    • Excellent communication, leadership, and collaboration abilities.
    • Strong knowledge of laboratory workflows and QC operations
    • Strong analytical skills and comfort with reporting and dashboards.
    This advertiser has chosen not to accept applicants from your region.
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    Senior Quality Assurance Systems

    Pune, Maharashtra AECOM

    Posted today

    Job Viewed

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    Job Description

    **Company Description**
    **Work with Us. Change the World.**
    At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
    There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
    We're one global team driven by our common purpose to deliver a better world. Join us.
    **Job Description**
    * Senior technical resource may serve as technical advisor for team
    * Provides specialized technical input to studies and design for staff's specific area of expertise.
    * Develops study and design procedures to facilitate high quality cost effective work by others.
    * Participates in interdisciplinary review of project deliverables.
    * Develops construction cost estimates and estimates of technical efforts for projects.
    * Uses expertise in all steps of completing discipline component of PS&E package.
    * Performs quality control review of design calculations or drawings.
    * Prepares technical specification sections.
    * Provides input to the development of engineering budget and schedule to meet requirements.
    **Qualifications**
    Engineering Graduate.
    Minimum experience of 10 years in project of similar nature in government/ PSU/ Corporation/ major infra project in Quality Assurance.
    **Additional Information**
    **About AECOM**
    AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
    AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2024. Learn more at aecom.com.
    **What makes AECOM a great place to work**
    You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.
    As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines.
    **ReqID:** J10131159
    **Business Line:** Transportation
    **Business Group:** DCS
    **Strategic Business Unit:** Europe & India
    **Career Area:** Engineering
    **Work Location Model:** On-Site
    **Legal Entity:** AEC India
    This advertiser has chosen not to accept applicants from your region.

    Senior Quality Assurance Systems

    Pune, Maharashtra AECOM

    Posted today

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    Job Description

    Job Description

    • Senior technical resource may serve as technical advisor for team
    • Provides specialized technical input to studies and design for staff's specific area of expertise.
    • Develops study and design procedures to facilitate high quality cost effective work by others.
    • Participates in interdisciplinary review of project deliverables.
    • Develops construction cost estimates and estimates of technical efforts for projects.
    • Uses expertise in all steps of completing discipline component of PS&E package.
    • Performs quality control review of design calculations or drawings.
    • Prepares technical specification sections.
    • Provides input to the development of engineering budget and schedule to meet requirements.


    Qualifications

    Engineering Graduate.

    Minimum experience of 10 years in project of similar nature in government/ PSU/ Corporation/ major infra project in Quality Assurance.



    Additional Information

    About AECOM  

    AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan. 

    AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients’ complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle – from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2024. Learn more at aecom.com. 

    What makes AECOM a great place to work  

    You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you’ll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you’ve always envisioned. Here, you’ll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity. 

    As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines. 

    This advertiser has chosen not to accept applicants from your region.

    Systems Quality Assurance Analyst

    Hyderabad, Andhra Pradesh WELLS FARGO BANK

    Posted today

    Job Viewed

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    Job Description

    About this role:

    Wells Fargo is seeking a.

    In this role, you will:
    • Develop a variety of system quality assurance testing initiatives for projects on software systems
    • Complete systems testing and create systems quality assurance testing strategies
    • Execute complex test plans and scripts to facilitate testing activities
    • Document and verify resolution of software and specification defects
    • Develop standards and procedures to determine release readiness and streamline testing process
    • Provide guidance, lead, and prioritize testing activities for projects
    • Work with teams to develop testing strategies and provide specific technical guidance on defects to developers
    • Lead implementation of complex initiatives impacting one or more lines of business
    • Understand and ensure compliance and risk management requirements are met
    • Work with other stakeholders to implement key risk initiatives
    Required Qualifications:
    • 5+ years of Systems Quality Assurance and systems or application testing experience, or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education
    Desired Qualifications
    • Overall 5+ years of experience in the Banking industry
    • 3+ years of in depth knowledge of payments testing, Payment investigations, wire transfers, ACH payments, Real time payments
    • Intermediate knowledge and understanding of test plans, test cases, test procedures, test scripts, and expected results
    • Specific knowledge of the following applications, products along with UAT/NRT/SIT for these products : ACI Worldwide projects (MTS), Volante Products (VolPay/EPE, Message Gateway) PEGA/Smart Investigate, SWIFT (MT messages, gateway, FIN, ISO, etc.), Straight Through Processing (STP), Risk Control System (RCS), RGW, Dodd-Frank, Voice Response Unit (VRU), Content Manager.
    • Experience using GMTS( Global Money Transfer System) or MTS (Money Transfer System) application
    • Experience with Wire Transfer application preferred.
    • Experience in User Acceptance development & implementation
    • Knowledge and understanding of business tools and processes
    • Strong analytical skills with high attention to detail and accuracy
    • Excellent verbal, written, and interpersonal communication skills
    • Ability to take on a high level of responsibility, initiative, and accountability
    • Strong time management skills and ability to meet deadlines
    • Experience developing and cultivating professional relationships
    • Ability to work effectively in a team environment
    Posting End Date:
    18 Jul 2025
    *Job posting may come down early due to volume of applicants.

    We Value Equal Opportunity

    Wells Fargo is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected characteristic.

    Employees support our focus on building strong customer relationships balanced with a strong risk mitigating and compliance-driven culture which firmly establishes those disciplines as critical to the success of our customers and company. They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions. There is emphasis on proactive monitoring, governance, risk identification and escalation, as well as making sound risk decisions commensurate with the business unit's risk appetite and all risk and compliance program requirements.

    Candidates applying to job openings posted in Canada: Applications for employment are encouraged from all qualified candidates, including women, persons with disabilities, aboriginal peoples and visible minorities. Accommodation for applicants with disabilities is available upon request in connection with the recruitment process.

    Applicants with Disabilities

    To request a medical accommodation during the application or interview process, visit Disability Inclusion at Wells Fargo .

    Drug and Alcohol Policy

    Wells Fargo maintains a drug free workplace. Please see our Drug and Alcohol Policy to learn more.

    Wells Fargo Recruitment and Hiring Requirements:

    a. Third-Party recordings are prohibited unless authorized by Wells Fargo.

    b. Wells Fargo requires you to directly represent your own experiences during the recruiting and hiring process.

    This advertiser has chosen not to accept applicants from your region.
     

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