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Job Title: Sr. Manager - Quality

Location: Delhi, India

Status: Full-Time

About PharmaSecure

PharmaSecure is a global track-and-trace, product authentication, and consumer engagement company that has helped protect over 8 billion packages through its technology-enabled solutions on hundreds of manufacturing lines. The codes printed are generated using its patented, encryption-based algorithm that provides unmatched security.

It has a proven track record of implementing minimal changes to the existing manufacturing process and negligible downtime of manufacturing lines by providing a solution that seamlessly integrates into the existing operations.

It’s proven serialization capabilities have enabled large pharmaceutical companies to meet different traceability requirements, as it ensures that pharma manufacturers exporting to various countries maintain regulatory compliances.

Other than being experts in global track-and-trace, product authentication, and consumer engagement, PharmaSecure is also an OEM for efficient machines to provide a full suite of software and hardware solutions under one umbrella.

Overview of Role

The Senior Manager – Quality will be responsible for ensuring the quality and compliance of software applications, IT systems, and related processes in alignment with regulatory requirements in the pharmaceutical sector. The role involves testing, validating, and verifying that all systems meet industry standards, including GxP compliance, 21 CFR Part 11, and other applicable regulations. The candidate should have a keen eye for detail, a strong understanding of pharma industry guidelines, and experience in software testing and validation.

Principal Responsibilities and Accountabilities

• Software Testing & Validation :
• Design and/or review manual and automated test cases for IT systems.
• Perform validation of pharma-related IT systems as per GMP guidelines.
• Ensure compliance with 21 CFR Part 11 and other global pharmaceutical regulatory standards.
• Ensure testing for all IT systems and applications is in-line with PhrmaSecure QMS.
• Supervise Manage defect tracking and resolution with development teams.
• Documentation :
• Prepare/Review validation documentation, including Test Plans, Test Scripts, Validation Protocols, and Reports (IQ/OQ/PQ).
• Maintain records of test results, issues identified, and corrective actions.
• Assist in maintaining Standard Operating Procedures (SOPs) and ensuring they are followed during testing and validation activities.
• Regulatory Compliance :
• Ensure IT systems and processes adhere to industry-specific regulatory standards (GxP, GMP, GAMP 5, and Data Integrity requirements) and maintain continuous compliance.
• Oversee both QA and Regulatory Affairs responsibilities to ensure alignment with evolving pharmaceutical and IT regulations.
• Act as the primary liaison for internal and external audits, ensuring all IT systems meet regulatory and compliance standards.
• Stay updated on regulatory changes affecting pharma IT systems and incorporate new requirements into QA and regulatory processes.
• Risk Management :
• Conduct risk assessments and develop mitigation strategies for IT systems.
• Identify potential risks and issues early in the development lifecycle to prevent system failures post-deployment.
• Collaboration & Support :
• Work closely with cross-functional teams (IT, Development, Manufacturing, Regulatory, etc.) to ensure a smooth transition of systems from development to production.
• Provide training and support to end-users for validated IT systems.
• Assist with internal and external audits, ensuring IT QA compliance is maintained.

Competencies

• Fluency in English.
• Excellent written and verbal communication skills.
• Excellent teamwork skills.
• Excellent attention to detail, quality and control.
• Proven ability to influence cross-functional teams without formal authority.

Required experience and knowledge

• 10 plus years of experience in IT Quality Assurance, preferably in the pharmaceutical or life sciences sector.
• Proven track record of validating GxP-compliant systems in a regulated environment.
• Familiarity with GAMP 5, 21 CFR Part 11, Data Integrity, and other relevant pharma regulations.
• Bachelor's or Master's degree in Information Technology, Computer Science, or a related field.
• Certifications like ISTQB, Six Sigma, or relevant QA certifications are a plus.
• Hands-on experience with test management tools (JIRA, HP ALM, etc.).
• Knowledge of SQL and scripting for database and application testing.
• Familiarity with automated testing tools (Selenium, QTP, etc.).
• Experience with ISO standards 9001 and 27001.
• Knowledge of Pharma machines validation will be an added advantage.

Compensation

Candidates that meet all the above requirements will be considered for competitive compensation commensurate with their experience.

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with relevant standards (e.g., ISO 9001, industry-specific certifications).
• Establish and monitor key quality metrics and performance indicators, implementing corrective and preventive actions (CAPA) as needed.
• Lead and manage the Quality Assurance team, providing guidance, training, and performance evaluations.
• Oversee all aspects of product quality, from raw material inspection to finished goods testing and release.
• Conduct internal audits and support external audits by regulatory bodies and customers.
• Collaborate with production, engineering, and R&D teams to identify and resolve quality issues promptly.
• Implement and manage statistical process control (SPC) techniques to monitor and control manufacturing processes.
• Develop and update quality control procedures, work instructions, and documentation.
• Investigate customer complaints related to product quality and implement effective solutions.
• Drive continuous improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes.
• Manage supplier quality assurance programs, including audits and performance monitoring.
• Ensure compliance with all applicable health, safety, and environmental regulations related to quality.
• Prepare regular reports on quality performance for senior management.
• Promote a strong quality culture throughout the organization.
• Stay current with evolving quality standards and best practices in the manufacturing industry.

• Design, develop, and implement QA strategies and test plans for automotive products.
• Conduct thorough inspections and testing of components, sub-assemblies, and finished vehicles.
• Analyze test data and product quality metrics to identify trends and areas for improvement.
• Collaborate with design and manufacturing engineers to address quality concerns and implement corrective actions.
• Ensure compliance with industry standards (e.g., IATF 16949, ISO 9001) and customer-specific requirements.
• Develop and maintain detailed quality documentation, including test reports and failure analysis.
• Perform root cause analysis for quality defects and implement preventive measures.
• Lead quality improvement initiatives and continuous improvement activities.
• Train and mentor junior QA personnel on quality standards and testing procedures.
• Manage supplier quality performance and conduct supplier audits.
• Stay updated on emerging quality trends and technologies in the automotive sector.
• Contribute to the continuous improvement of the company's quality management system.

About Us

GVR Technolabs Pvt Ltd , an Information Technology services company with expertise in design, deployment and management of hardware and software applications and technology infrastructures. We offer services to improve our clients efficiency, strengthen partnerships, increase profitability, and improve business processes with quality and value in a secure environment.

Designation: Software Quality Assurance (IV & V Services)

Locations: Delhi

Qualification: B.Tech/BE/M.Tech/ME in ECE/CSE/EEE/ECE/E & TCE or MSc (CS) or MCA

Experience Required

   2 Years for Regular level

   4 Years for High level

Roles & Responsibilities:

• Checklists tailoring and compliance verification for specific Lab/Estt. needs
• Analysis of software code, design and related artifacts (code, documents, scripts) and preparation of reports
• High level requirements to low level requirements to design to implementation to test cases traceability and report generation
• Execution of test vectors, generation of test oracles / data set
• Test coverage based on test execution plan and report generation
• Execution of functional, non-functional and endurance tests w.r.t ATP document
• First level identification, reporting verification on closure of defects & bug
• Review of documentation for completeness, consistency, traceability and reporting
• Test measurements reports generation and analysis
• Static and dynamic testing reports generation and review
• Development of automated regression test suites and regression testing based as per test plans.
• Test report generation for certification, where applicable
• Preparation of required documentation for the air-worthiness certification or equivalent certifications for all levels of criticality
• Generation of result reports for the IV&V activities carried out
• Use of configuration tools for software configuration control
• Configuration audits and report generation
• Software quality metrics data recording and analysis, and reporting
• Review of requirements, design, interfaces/ protocols and documents and release the review reports/ audit reports
• Verification/ updating of low level test plan, test cases and test procedures (Unit testing and module testing)
• Integration testing and analysis and report generation
• Requirements based testing &test case generation w.r.t functional requirements
• Generation of endurance test cases and realization of endurance test beds.
• Generation of smoke &sanity tests results, review and validation of the same
• Reverification of identification and reporting on closure of defects & bugs
• Verification of test beds/prototypes similar to deliverable system
• Development of test procedure and test scripts for HSI testing based on requirements
• Execution & reporting and review of HSI testing
• Phase checks, Integration testing and analysis of final V&V reports
• End to end traceability review
• Generation and verification of functional and non-functional requirement test cases.
• Code walkthrough and review and reporting
• Object code testing and review and reporting
• FPGA/ Verilog/ VHDL code review and reporting
• Third party library testing and report generation
• Verification of software tool qualification and documentation
• Impact analysis and change request-based testing and regression analysis
• Mutation testing with debugging, fault injection at unit, component & system level
• Defect identification and tracking
• Preparation and management of trace data
• Development/ updation of software IV&V plan as per the standard/ guidelines
• Testing using jigs, simulators and test beds
• Define IV&V processes and methodologies
• Review and validation of all test plans, suites and results including automated regression test suites
• Analysis of software quality metrics data as per established process and product metrics
• Audit of all reviews
• Audit of all IV&V processes
• Validation of deliverable systems w.r.t functional and non-functional requirements
• Behavioral testing and reliability assessment
• Generation/ validation of FAT and ATP documents
• Review of all documents related to qualification and certification and release the same

Requirements

• Flight control software (S/W residing on on-board computers of launch vehicles) and on-board mission systems and avionics
• Ground based software (S/W residing in checkout systems and simulation test facilities of launch vehicles)
• Ground based armament and combat systems
• Verification simulators software and Test rig software
• Mission planning, design and training Software
• Engine control software
• Radar and Communication software Signal processing & analysis software
• Shipborne/ Under water systems software
• Simulation & Modeling software
• Other software required to build mission critical / safety critical systems
• Other general-purpose software in Aerospace and Defence domain.
• Other software application using web technologies and RDBMS

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with global regulatory requirements.
• Oversee all quality assurance activities, including batch record review, product release, and deviation management.
• Conduct regular internal audits of manufacturing processes, laboratories, and documentation to ensure compliance.
• Manage external audits from regulatory authorities and customers, coordinating responses and follow-up actions.
• Investigate product quality complaints, deviations, and out-of-specification (OOS) results, implementing robust CAPA plans.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
• Develop and deliver quality training programs for relevant personnel.
• Review and approve validation protocols and reports for equipment, processes, and analytical methods.
• Manage supplier quality, including qualification, auditing, and performance monitoring.
• Lead continuous improvement initiatives aimed at enhancing product quality, process efficiency, and regulatory compliance.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP, regulatory guidelines (e.g., FDA, EMA), and quality systems.
• Proven experience in conducting and managing audits (internal and external).
• Strong understanding of pharmaceutical manufacturing processes, validation, and stability studies.
• Excellent analytical, problem-solving, and decision-making skills.
• Effective leadership and team management abilities.
• Strong written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in using quality management software and ERP systems.
• Ability to work effectively in a regulated manufacturing environment.

• Oversee and manage the Quality Management System (QMS) for pharmaceutical products.
• Ensure compliance with GMP, GLP, and other relevant regulatory standards.
• Lead the review and approval of batch records, specifications, and validation protocols.
• Manage deviation investigations, root cause analysis, and CAPA implementation.
• Conduct internal audits and support external regulatory inspections.
• Develop and implement quality training programs for personnel.
• Monitor and analyze quality metrics to drive continuous improvement.
• Collaborate with R&D, manufacturing, and regulatory affairs departments.
• Approve or reject raw materials, intermediates, and finished products.
• Stay abreast of evolving pharmaceutical regulations and quality best practices.

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global regulations.
• Oversee and manage all QA activities, including batch record review, release, deviation investigations, CAPA, and change control.
• Lead internal audits and host regulatory agency inspections (e.g., FDA, EMA) and customer audits.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant industry standards.
• Develop and execute validation master plans and protocols for equipment, processes, and systems.
• Review and approve product quality related documentation, ensuring accuracy and completeness.
• Manage and mentor a team of Quality Assurance professionals, fostering their development and performance.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure quality is built into products and processes.
• Drive continuous improvement initiatives within the QA function to enhance efficiency and compliance.
• Stay updated on evolving regulatory requirements and industry best practices.

• Master's degree or Ph.D. in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life science field.
• Minimum of 8-10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of GMP, ICH guidelines, and global regulatory requirements.
• Proven experience in managing QMS, conducting audits, and leading regulatory inspections.
• Strong leadership, team management, and interpersonal skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional written and verbal communication skills.
• Ability to work independently and effectively in a fully remote environment.