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Job Description – Officer QA
Department:
Quality Assurance

Designation:
Officer – QA

Reporting To:
Assistant Manager / Manager – QA

Location:
Navi Mumbai
- Job Purpose

To support Quality Assurance activities in a pharmaceutical analytical testing laboratory, with specific responsibility for
Computer System Validation (CSV) execution and documentation, analytical data review, review of instrument qualification/calibration records and ensuring compliance with applicable GMP, GLP, data integrity and laboratory quality requirements.
- Key Responsibilities
- Computer System Validation (CSV)
- Support and execute Computer System Validation activities for laboratory computerized systems in accordance with approved validation procedures and applicable regulatory expectations.
- Review and/or execute validation documents including:
- User Requirement Specifications (URS)




- Functional/Design Specifications
- Risk Assessments
- Validation Plans
- Configuration/Installation/Operational Qualification documents
- User Acceptance Testing (UAT)
- Traceability Matrix
- Validation Summary Reports
- Participate in assessment of GxP applicability, data integrity, audit trails, electronic records and electronic signatures.
- Execute or coordinate validation test cases and document test results, deviations and evidence.
- Review validation documentation and ensure that requirements are adequately tested and traceable.
- Support periodic review, change control, access management and revalidation activities for computerized systems.
- Work with IT, laboratory and system vendors to resolve validation-related issues.
- Instrument Qualification Data Review
- Review qualification documentation for laboratory instruments and computerized analytical systems.
- Review DQ/IQ/OQ/PQ and requalification records,

📌 Officer - QA (Navi Mumbai)
🏢 ALS
📍 Navi Mumbai