- Prepare, execute, and compile Computer System Validation (CSV) activities as per GAMP 5.
- Maintain validation lifecycle documentation including URS, risk assessments, validation protocols, reports, and traceability.
- Ensure computerized systems comply with 21 CFR Part 11 and EU GMP Annex 11.
- Ensure data integrity, electronic records, and e-signature compliance.
- Perform periodic review and requalification of computerized systems.
- Handle Change Control, CAPA, Deviations, Risk Assessments, and investigations related to computerized systems.
- Support IQ/OQ/PQ and validation activities for GxP computerized systems.
- Review system configurations, access controls, audit trails, and security requirements.
- Coordinate with QA, IT, Engineering, and system owners for CSV activities.
- Support internal audits, regulatory inspections, and compliance assessments related to computerized systems.
- Prepare/review SOPs, validation plans, protocols, and reports.
- Ensure computerized systems

📌 CSV Executive (Mumbai)
🏢 BVR People Consulting
📍 Mumbai