Manager - IT QA & CSV

Key Responsibilities: Computerized System Validation (CSV): - Provide validation expertise on GxP-compliant applications in the drug safety space. - Serve as SME in CSV practices , ensuring best practices are consistently followed. - Review and approve key CSV deliverables: Requirement Specifications, Validation Plans, Test Plans, Traceability Matrix, Test Summary Reports, Qualification Scripts, and Validation Summary Reports. - Lead validation and UAT activities for client product implementation projects. - Guide the testing team in manual and automated testing , OQ, PQ, IQ, and other SDLC artifacts. - Support internal QA team during client, internal, and regulatory audits . - Apply risk-based system validation approaches and the V-Model methodology. - Collaborate with SMEs for requirements analysis, risk assessment, profiling, and mitigation . - Oversee Change Control, Deviation Handling, Document Management, and CAPA procedures. Quality Assurance Operations: - Maintain strong knowledge of GxP, GDP, GTP, QA best practices and regulatory compliance (FDA, EMA, MHRA, PMDA). - Ensure adherence to 21 CFR Part 11 and EU Annex 11 guidelines. - Anchor updates to QMS and participate in continual improvement programs . - Coordinate revision, review, and approval of IT SOPs and GxP documents . - Train and mentor resources on QA practices and CSV . Team and Stakeholder Management: - Manage, mentor, and coach a team of QA professionals, including onboarding, career development, and performance evaluation. - Engage with clients to build confidence and maintain relationships. - Conduct capacity planning and resource forecasting . - Ensure effective management of multiple projects while maintaining the balance between quality and productivity. - Oversee cross-training of staff and promote teamwork and motivation . Skills: System Testing, Functional Testing, Test Planning, Manual Testing, Risk Assessment, Document Management Experience: 10.00-20.00 Years