Job Title: CSV Engineer
Location: Bangalore
Experience: 1 -7 years
Industry: Pharmaceutical / Biotechnology / Lifesciences
About the Role:
We are looking for an experienced Computer System Validation (CSV) professional to support validation activities for Gx P-regulated computerized systems. The role involves executing validation deliverables, ensuring regulatory compliance, and working closely with cross-functional teams to maintain system integrity throughout the lifecycle.
Key Responsibilities:
- Perform validation activities for Gx P computerized systems (planning, risk assessment, summary reports).
- Prepare and review validation documentation including URS, FRS, RA, IQ, OQ, PQ, and Traceability Matrix.
- Support validation of systems such as LIMS, QMS, ERP, MES, CDS, and laboratory instruments.
- Contribute to SOP creation and updates related to computerized systems.
- Execute and support CSV activities in line with GAMP 5, 21 CFR Part 11, EU Anne...