Job Description
We are looking for a skilled Computer System Validation (CSV) Engineer to support validation and compliance activities for computerized systems in a regulated pharmaceutical environment. The ideal candidate should have experience in GxP compliance, validation lifecycle management, and regulatory standards such as GAMP 5 and 21 CFR Part 11.
Key Responsibilities
- Execute Computer System Validation (CSV) activities for GxP systems.
- Prepare and review validation documents including URS, Risk Assessment, IQ, OQ, PQ, Traceability Matrix, and Validation Reports.
- Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and Data Integrity requirements.
- Validate systems such as LIMS, ERP, SCADA, BMS, MES, ELN, and laboratory instruments.
- Perform risk assessments, change control evaluations, deviation investigations, and CAPA activities.
- Coordinate with QA, IT, Engineering, Production, and vendors during validation projects.
- Support audits and regulatory inspections while maintaining validation documentation.
Required Skills
- Strong knowledge of CSV lifecycle and GxP regulations.
- Hands-on experience with IQ/OQ/PQ documentation.
- Knowledge of GAMP 5, 21 CFR Part 11, Data Integrity (ALCOA+).
- Experience with Pharma systems such as LIMS, ERP, MES, SCADA, BMS, CDS, or ELN.
- Good documentation and stakeholder management skills.
Pay: ₹323,137.10 - ₹516,243.47 per year
Experience:
- CSV Engineer: 2 years (Required)
Work Location: In person
