Job Description
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 GxP-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 GxP 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...
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 GxP-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 GxP 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...