7,160 Qa Management jobs in India

Senior QA- Release Management Engineer

Bengaluru, Karnataka ₹1500000 - ₹2500000 Y KVP Business Solutions

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Job Description

About the Role:

We are looking for a Senior QA & Release Management Engineer to ensure data correctness, maintain platform performance, and execute smooth, predictable releases for our multi-tenant SaaS platform. You will work closely with Development, Product, and Analytics teams to deliver high-quality releases and maintain platform reliability.

Key Responsibilities:

  • Define and maintain cross-platform data checks and reconciliation routines.
  • Perform regression testing for campaigns, ads, conversions, and metrics like CTR/CVR/ROAS.
  • Own release planning, UAT, go/no-go decisions, and production deployments.
  • Manage staged rollouts, canary releases, rollback playbooks, and CI/CD quality gates.
  • Plan and execute performance tests (load, stress, spike, soak) using tools like k6 or JMeter.
  • Monitor performance, SLOs, and dashboards; identify and resolve bottlenecks.

Must-Have Skills:

  • 7- 8 years in QA & Release Management for SaaS/web products.
  • Hands-on API and data validation experience.
  • Strong knowledge of CI/CD pipelines, Git, Jenkins, GitHub Actions/GitLab CI/CD.
  • Experience with performance testing tools: k6, JMeter; observability tools: Grafana, Prometheus, Datadog.
  • Excellent communication and decision-making for release management.

Nice-to-Have:

  • Experience with Google Cloud Platform (GCP).
  • Familiarity with Jira/Xray, TestRail, feature flags.
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AVP, Test Management

Chennai, Tamil Nadu ₹1200000 - ₹3600000 Y Standard Chartered Bank

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Job Description

Job ID: 37806

Location: Chennai, IN

Area of interest: Technology

Job type: Regular Employee

Work style: Office Working

Opening date: 23 Sept 2025

Job Summary

The Test Manager will be a key member of Trade Test Engineering team and responsible for delivering the test plan, lead the squad testers and end-end testing. Lead test Engineer should possess technical skills, combined with strong analytical, problem-solving, and communication skills, are essential for a Lead Test Engineer to effectively lead testing efforts and ensure the quality of software products. The role holder will form a key part of a fast-paced, ambitious, delivery programme.

Key Responsibilities

  • Run end to end Program across QA activities from Test Strategy, Schedule, planning, Execution, Reporting till TCR
  • Test Automation execution by using various Automation Tools
  • ADO Defect Management
  • Experience in SQL queries, Stored Procedures, Jobs creations
  • Work independently with several teams across the ITO organisation (Dev, Tech, Infra, Prod Support etc) to deliver a world class testing solution and architecture within the Trade & Cash ITO space
  • Provide a pragmatic view of risk & stability vs project delivery timelines to provide a high quality solution within a realistic timescale
  • Manage offshore teams in remote locations in India and Malaysia
  • Manage change in scope, requirements etc and plan for these in the testing strategy and planning
  • Estimate and obtain management support for the time, resources and budget required to perform the testing.
  • Define the testing Strategy
  • Develop the testing plan for tasks, dependencies and participants required to mitigate the risks to system quality and obtain stakeholder support for this plan.
  • Document, implement, monitor, and enforce all processes for testing as per standards
  • Keep track of the new requirements / change in requirements of the Project.
  • Organize the status meetings and send the Status Report (Daily, Weekly etc.) to the Client
  • Attend the regular stakeholder calls
  • Act as the single point of contact between Development and Testing teams.
  • Design, track and prepare the report of testing activities like test testing results, test case coverage, required resources, defects discovered and their status, performance baselines etc.
  • Review various reports prepared by Test engineers.
  • Ensure the timely delivery of different testing milestones.
  • Prepares / updates the metrics dashboard at the end of a phase or at the completion of project.
  • Build a testing team of professionals with appropriate skills, attitudes and motivation.
  • Identify Training requirements for up skilling the talent within the testing teams (Technical and Soft skills)

  • Run end to end Program across QA activities from Test Strategy, Schedule, planning, Execution, Reporting till TCR

  • Test Automation execution by using various Automation Tools
  • ADO Defect Management
  • Knowledge in SQL queries, Stored Procedures, Jobs creations
  • Creative to resolve challenges during testing
  • Courageous to take tough decisions in the interest of project
  • Prepare Closure report and Quality Gate checklist
  • Ensure compliance to UTM and SDF models
  • Excellent understanding of Test Strategy, Test Traceability, Test Evidences, and Test Closure Report which form UTM (Unified Test Model) pillars under SCB's System Delivery Framework
  • Foster an open culture within the team
  • Sound knowledge on risk assessment and risk management
  • Promote equality within the team
  • Raise appropriate Risk, Issues, Dispensation whenever required
  • Prepare User guides, Business Cases, Training Material

Skills and Experience

  • Relevant experience of 15+ years
  • Banking/Fintech experience mandatory
  • Trade Finance domain experience is mandatory
  • Strong understanding of manual testing techniques and methodologies.
  • Ability to create detailed, comprehensive, and well-structured test plans and test cases.
  • Continuous Integration/Continuous Deployment (CI/CD):
  • Familiarity with CI/CD tools such as Jenkins, GitLab CI, or CircleCI.
  • Experience in integrating automated tests into the CI/CD pipeline.
  • Experience with defect tracking tools like JIRA, ADO.
  • Familiarity with test management tools like QTest
  • Knowledge of SQL and experience with database testing.
  • Ability to write and execute complex SQL queries.
  • Agile/Scrum Methodologies:
  • Understanding of Agile and Scrum methodologies.
  • Experience working in Agile development environments.
  • Basic knowledge of security testing principles and tools.
  • Ability to identify and report security vulnerabilities.

Qualifications

  • Bachelor's Degree in Computer Science, Software Engineering or equivalent degree

About Standard Chartered

We're an international bank, nimble enough to act, big enough for impact. For more than 170 years, we've worked to make a positive difference for our clients, communities, and each other. We question the status quo, love a challenge and enjoy finding new opportunities to grow and do better than before. If you're looking for a career with purpose and you want to work for a bank making a difference, we want to hear from you. You can count on us to celebrate your unique talents and we can't wait to see the talents you can bring us.

Our purpose, to drive commerce and prosperity through our unique diversity, together with our brand promise, to be here for good are achieved by how we each live our valued behaviours. When you work with us, you'll see how we value difference and advocate inclusion.

Together we:

  • Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do
  • Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well
  • Are better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term

What we offer

In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing.

  • Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations.
  • Time-off including annual leave, parental/maternity (20 weeks), sabbatical (12 months maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum.
  • Flexible working options based around home and office locations, with flexible working patterns.
  • Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits
  • A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning.
  • Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies - everyone feels respected and can realise their full potential.
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SAP test management

Karnataka, Karnataka ObjectWin Technology India Pvt. Ltd

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Job Description

Must to have skillset

Good to have skillset

Anymore inputs

1. Functional Testing
2. E2E Test Management - Test Preparation and Planning, Test Execution, Test Reporting and cutover
3. Creating Test Deliverables for example Test Plan, Test Strategy, E2E Test scripting, Test Data Identification and preparation etc
4. Driving E2E User Acceptance Testing Preparation, Planning and Execution
5. Defect Management, trouble-shooting issues, providing inputs for resolution
6. Stakeholder Management - Effective coordination with Business, IT Team, PM
7. SAP Testing Background
8. Hands-on experience in Test Management Tools

1. Test Automation
2. Supply Chain and Logistics

1. Flexible to work in EMEA and/or APAC time zones
2. Should be able to support multiple projects at a time.
3. Good Communication and Presentation skill

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Quality Engineer-Test Management

Mumbai, Maharashtra IBM

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Job Description

**Introduction**
In this role, you'll work in one of our IBM Consulting Client Innovation Centers (Delivery Centers), where we deliver deep technical and industry expertise to a wide range of public and private sector clients around the world. Our delivery centers offer our clients locally based skills and technical expertise to drive innovation and adoption of new technology.
**Your role and responsibilities**
* Manage and engineer Quality for S/4 HANA implementation or upgrade or conversion programs.
* Design/Create and Implement Test strategies for large SAP programs (Implementation, Upgrade and S/4 Transformation).
* Create test plan and procedures.
* Test Coordination and manage multiple test cycles.
* Drive end to end Integration testing
**Required technical and professional expertise**
* Self-driven individual with a sense of accountability and ownership of program quality.
* Good working knowledge of automation tools like WorkSoft or TOSCA.
* Thorough knowledge of creating test plans, coordinating, and managing test processes and testing of end user applications.
* Experience with working in a multi-location / international company. Excellent communication skills, Flexible, dynamic personality who works well partnering/collaborating in a matrixed team environment.
* Demonstrated experience and ability to deliver results on multiple projects in a fast-paced, agile environment
**Preferred technical and professional experience**
* Overall, 12-25 years of experience with a relevant of 7-8 years of work experience in SAP programs (Implementation, Upgrade and S/4 Transformation).
* Experience in an SAP Test Management for at least 4 years.
* Experience in Test management tools like Microfocus ALM, ADO, QTEST, JIRA, etc
IBM is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, caste, genetics, pregnancy, disability, neurodivergence, age, veteran status, or other characteristics. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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Quality Analyst – Test Management

Gandhinagar, Gujarat ₹800000 - ₹1800000 Y Fintech Global Center

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About the job

Job Title: Quality Analyst – Test Management

Location: Gandhinagar, Gujarat

Company: Fintech Global Center Private Limited

Job Type: Full-Time

Experience Required: 3+ Years

Work Mode: Onsite (Hybrid flexibility can be discussed)

About Us At Fintech Global Center, we're building cutting-edge technology solutions for the global financial ecosystem. We are looking for an experienced Senior Quality Analyst who can own the QA process, lead a growing team, and ensure product excellence across all releases.

Role Overview This is a leadership-focused QA role that goes beyond testing. We need someone who can manage test execution, mentor team members, and collaborate effectively with cross-functional teams. A strong understanding of QA methodologies and automation is important, but the emphasis is on ownership, communication, and delivery.

  • Key Responsibilities Leadership & Team Management Lead and mentor a team of QA analysts and testers.
  • Define and enforce best practices in test planning, test case design, and defect tracking.
  • Coordinate with Product Owners, Developers, and DevOps teams to drive quality throughout the SDLC.
  • Test Management & Execution Own the end-to-end QA lifecycle — from requirement analysis to sign-off.
  • Plan, prioritize, and manage multiple testing initiatives in parallel.
  • Design and maintain test cases, scenarios, and regression test suites.
  • Ensure timely test execution and detailed test reporting.
  • Leverage generative AI to create, optimize, and manage test cases from user stories or design inputs (where applicable).
  • Automation & Tools Hands-on experience with automation testing (e.g., Selenium, Playwright, or equivalent).
  • Implement or contribute to automation frameworks as needed.
  • Bug Tracking & Reporting Use tools like Jira/TestRail to report and manage defects.
  • Work closely with developers to reproduce, prioritize, and resolve issues.
  • What We're Looking ForMust-Have:3+ years of experience in software testing with exposure to both manual and automation testing.
  • Strong understanding of SDLC, STLC, and QA methodologies.
  • Proven experience in leading small to mid-sized QA teams.
  • Excellent communication, reporting, and coordination skills.
  • Strong ownership mindset with the ability to work independently and collaboratively.
  • Good to Have: Exposure to test automation frameworks and CI/CD pipelines.
  • Familiarity with AI-driven test automation tools such as Testim, Mabl, Applitools, Functionize, or TestRigor.
  • Experience using or exploring generative AI to support test creation and maintenance.
  • Domain knowledge in fintech or financial products, especially derivatives, is a plus.

Education : Bachelor's degree in Computer Science, Information Technology, or a related field.

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Sr. Quality Analyst – Test Management

Gandhinagar, Gujarat ₹120000 - ₹180000 Y Fintech Global Center

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Job Description

Job Title:
Sr. Quality Analyst – Test Management & Team Lead

Location:
Gandhinagar, Gujarat

Company:
Fintech Global Center Private Limited

Job Type:
Full-Time

Experience Required:
3+ Years

Work Mode:
Onsite (Hybrid flexibility can be discussed)

About Us

At
Fintech Global Center
, we're building cutting-edge technology solutions for the global financial ecosystem. We are looking for an experienced
Senior Quality Analyst
who can
own the QA process, lead a growing team, and ensure product excellence
across all releases.

Role Overview

This is a leadership-focused QA role that goes beyond testing. We need someone who can
manage test execution
,
mentor team members
, and
collaborate effectively with cross-functional teams
. A strong understanding of QA methodologies and automation is important, but the emphasis is on
ownership, communication, and delivery
.

Key Responsibilities

Leadership & Team Management

  • Lead and mentor a team of QA analysts and testers.
  • Define and enforce best practices in test planning, test case design, and defect tracking.
  • Coordinate with Product Owners, Developers, and DevOps teams to drive quality throughout the SDLC.


Test Management & Execution

  • Own the end-to-end QA lifecycle — from requirement analysis to sign-off.
  • Plan, prioritize, and manage multiple testing initiatives in parallel.
  • Design and maintain test cases, scenarios, and regression test suites.
  • Ensure timely test execution and detailed test reporting.
  • Leverage generative AI to create, optimize, and manage test cases from user stories or design inputs
    (where applicable).


Automation & Tools

  • Hands-on experience with automation testing (e.g., Selenium, Playwright, or equivalent).
  • Implement or contribute to automation frameworks as needed.


Bug Tracking & Reporting

  • Use tools like Jira/TestRail to report and manage defects.
  • Work closely with developers to reproduce, prioritize, and resolve issues.

What We're Looking For
Must-Have:

  • 3+ years
    of experience in software testing with exposure to both manual and automation testing.
  • Strong understanding of SDLC, STLC, and QA methodologies.
  • Proven experience in
    leading small to mid-sized QA teams
    .
  • Excellent
    communication, reporting, and coordination skills
    .
  • Strong ownership mindset with the ability to work independently and collaboratively.

Good to Have:

  • Exposure to test automation frameworks and CI/CD pipelines.
  • Familiarity with
    AI-driven test automation tools
    such as
    Testim, Mabl, Applitools, Functionize, or TestRigor
    .
  • Experience using or exploring generative AI to support test creation and maintenance.
  • Domain knowledge in fintech or financial products
    , especially derivatives, is a plus.

Education

Bachelor's degree in Computer Science, Information Technology, or a related field.

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

Case Management QA Vendor Associate

Hyderabad, Andhra Pradesh Amgen

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Job Description

**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Case Management QA Vendor Associate**
**What you will do**
Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support.
+ Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors
+ Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements
+ Provide vendors with resources and training to perform their role
+ Analysis and communication of case Quality Control results
+ Responsible for escalation of case related issues from vendor(s)
+ Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable
+ Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
+ May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
+ Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor · Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
+ Ensure vendor case processing timelines for AE intake, triage and submission are met
+ Perform retrospective quality assurance of vendor processed cases
+ Day-to-day vendor management issues
+ Interact with other local safety offices as applicable
+ Support on-boarding and off-boarding of vendor staff
+ Attend management meetings with vendors
+ Support analysis of QC trends
+ Support generating, communicating, and archiving of reports of QC findings
+ Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
+ Perform case review as required
+ Generate and distribute performance metrics (retro QA / Case correction)
+ Support analysis of QC trends including actions/recommendations
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The (vital attribute) professional we seek is a (type of person) with these qualifications.
**Basic Qualifications:**
+ Bachelor's degree and 3 years of directly related experience (OR)
+ Associate's degree and 5 years of directly related experience (OR)
+ High school diploma / GED and 7 years of directly related experience (AND)
+ Previous experience directly managing teams, projects, programs or directing the allocation of resources
**Preferred Skills:**
+ Understanding of global regulatory requirements for pharmacovigilance
+ Proficiency in safety case processing
+ Expertise in all aspects of case intake and processing in multiple global safety databases
+ Experience in supporting inspections or internal audits
+ Communication skills and attention to detail
+ Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This advertiser has chosen not to accept applicants from your region.
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Case Management QA Vendor Associate

Hyderabad, Andhra Pradesh ₹500000 - ₹1200000 Y Amgen Inc

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Job Description

*What you will do *

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support.

  • Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors
  • Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements
  • Provide vendors with resources and training to perform their role
  • Analysis and communication of case Quality Control results
  • Responsible for escalation of case related issues from vendor(s)
  • Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable
  • Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
  • May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
  • Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
  • Ensure vendor case processing timelines for AE intake, triage and submission are met
  • Perform retrospective quality assurance of vendor processed cases
  • Day-to-day vendor management issues
  • Interact with other local safety offices as applicable
  • Support on-boarding and off-boarding of vendor staff
  • Attend management meetings with vendors
  • Support analysis of QC trends
  • Support generating, communicating, and archiving of reports of QC findings
  • Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
  • Perform case review as required
  • Generate and distribute performance metrics (retro QA / Case correction)
  • Support analysis of QC trends including actions/recommendations

Basic Qualifications:

  • Bachelors degree and 3 years of directly related experience (OR)
  • Associates degree and 5 years of directly related experience (OR)
  • High school diploma / GED and 7 years of directly related experience (AND)
  • Previous experience directly managing teams, projects, programs or directing the allocation of resources

Preferred Skills:

  • Understanding of global regulatory requirements for pharmacovigilance
  • Proficiency in safety case processing
  • Expertise in all aspects of case intake and processing in multiple global safety databases
  • Experience in supporting inspections or internal audits
  • Communication skills and attention to detail
  • Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
This advertiser has chosen not to accept applicants from your region.

QA - Material Master Management (SAP)

Ahmedabad, Gujarat ₹500000 - ₹1000000 Y Unison Pharmaceuticals

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Job Description

Excellent job opportunity for QA - Material Master Management (SAP) @Unison Pharmaceuticals Pvt Ltd, Moraiya, Ahmedabad

About us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and affordable medicines across the nation. With more than 4 decades of medical service to society, Unison is today one of the fastest-growing companies in Gujarat State. In addition to this, the company is ranked 82 among the top companies of India (Rupee wise sales) MAT March 2020. This makes Unison a distinguished company across the pharma industry.

Experience: 2 to 6 years

Job Role: QA - Material Master Management (SAP)

Designation: Officer / Sr. Officer

Location: Moraiya, Ahmedabad (Transportation is available from specific routes of Ahmedabad)

Roles and Responsibilities :

  • Semi-Finished Product (SF) code allocation & creation in SAP system
  • Finished Product (FP) code allocation & creation in SAP system.
  • Bill of Material creation as per MFC/MPC/BMR in SAP system.
  • Maintain SF &FG code Creation Excel & Logbook
  • Communication with CFT with respect to code creation activity.

Perks & Benefits

  • Dynamic work environment
  • Career development opportunities
  • Work-life balance
  • Free transportation
  • Canteen Facility
  • Free insurance coverage for self, spouse, and kids
  • Range of learning opportunities to help employees grow and thrive

If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position.

Interested one can share updated resume on to be considered for this role.

Join our team and take the first step towards a rewarding career

Regards,

Team HR

Unison Pharmaceuticals Pvt Ltd

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Case Management QA Vendor Sr Associate

Hyderabad, Andhra Pradesh Amgen

Posted today

Job Viewed

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Job Description

**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Case Management QA Vendor Sr Associate**
**What you will do**
Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support.
+ Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors
+ Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements
+ Provide vendors with resources and training to perform their role
+ Analysis and communication of case Quality Control results
+ Responsible for escalation of case related issues from vendor(s)
+ Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable
+ Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
+ May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable
+ Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor · Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes
+ Ensure vendor case processing timelines for AE intake, triage and submission are met
+ Perform retrospective quality assurance of vendor processed cases
+ Day-to-day vendor management issues
+ Interact with other local safety offices as applicable
+ Support on-boarding and off-boarding of vendor staff
+ Attend management meetings with vendors
+ Support analysis of QC trends
+ Support generating, communicating, and archiving of reports of QC findings
+ Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
+ Perform case review as required
+ Generate and distribute performance metrics (retro QA / Case correction)
+ Support analysis of QC trends including actions/recommendations
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The (vital attribute) professional we seek is a (type of person) with these qualifications.
**Basic Qualifications:**
+ Master's degree and 3 years of directly related experience (OR)
+ Bachelor's degree and 5 years of directly related experience (OR)
+ Associate's degree and 10 years of directly related experience (OR)
+ High school diploma / GED and 12 years of directly related experience (AND)
+ Previous experience directly managing teams, projects, programs or directing the allocation of resources
**Preferred Skills:**
+ Understanding of global regulatory requirements for pharmacovigilance
+ Proficiency in safety case processing
+ Expertise in all aspects of case intake and processing in multiple global safety databases
+ Experience in supporting inspections or internal audits
+ Communication skills and attention to detail
+ Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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