CSV Executive (Mumbai)

CSV Executive (Mumbai)

02 Sep
|
BVR People Consulting
|
Mumbai

02 Sep

BVR People Consulting

Mumbai

- 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

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