CSV Consultant – Key Responsibilities & Skills

- Execute CSV activities for GxP-regulated pharmaceutical systems.
- Conduct gap assessments and retrospective validation.
- Prepare URS, FRS, risk assessments, RTM, IQ/OQ/PQ, and VSR documentation.
- Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+.
- Perform system impact, risk, and data integrity assessments.
- Validate laboratory and manufacturing systems, including PLC, SCADA, and HMI.
- Review test scripts, execution evidence, and validation deliverables.
- Support change control, deviations, CAPA, and compliance remediation.
- Maintain audit readiness and Valuable Documentation Practices (GDP).

We are looking for an immediate Joiners

📌 Sr Computer System Validation (Bengaluru)
🏢 Diensten Tech
📍 Bengaluru