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