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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
A. 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.

B. Instrument Qualification Data Review
Review qualification documentation for laboratory instruments and computerized analytical systems.
Review DQ/IQ/OQ/PQ and requalification re

📌 Officer Qa Navi Mumbai
🏢 ALS Global
📍 Navi Mumbai