Test Lead (GxP/CSV)

Job Title Test Lead (GxP / CSV) Role Overview Seeking an experienced Test Lead / QA Engineer with strong expertise in GxP-regulated environments and Computer System Validation (CSV). The role involves leading validation and testing activities for regulated systems, ensuring compliance with industry standards such as FDA 21 CFR Part 11, GAMP 5, and other applicable regulatory guidelines. The candidate will be responsible for test strategy, validation documentation, execution oversight, and ensuring audit-ready quality processes across validated systems. Key Responsibilities Lead validation and testing activities for GxP-regulated systems and applications. Define and implement test strategy, test plans, and validation approaches for CSV projects. Review and approve validation deliverables including URS, FS, DS, RTM, IQ, OQ, and PQ documents. Ensure compliance with regulatory standards such as FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and internal QA policies. Coordinate and manage end-to-end validation lifecycle activities. Develop and execute test cases for functional, integration, regression, and UAT testing. Perform risk-based testing and ensure appropriate test coverage for critical business processes. ts for system changes, upgrades, and new implementations. Collaborate with business users, QA teams, developers, and compliance teams. Ensure traceability between requirements and test cases through RTM (Requirements Traceability Matrix). Mentor and guide QA testers and junior validation team members. Review and improve validation processes to enhance efficiency and compliance. Participate in release planning and change control processes. Required Skills Strong experience in Software Testing / QA with focus on GxP and CSV environments. Hands-on experience in preparing and reviewing validation deliverables (IQ, OQ, PQ). Strong understanding of GAMP 5 guidelines and validation lifecycle processes. Experience working in regulated industries such as Pharma, Life Sciences, Healthcare, or Medical Devices. Knowledge of FDA 21 CFR Part 11 compliance requirements. Strong experience in test planning, test case design, and execution. Experience in defect lifecycle management and test management tools (e.g., JIRA, ALM, Zephyr). Strong understanding of SDLC and STLC processes. Experience in requirements analysis and traceability management (RTM). Strong documentation and analytical skills.