Csv engineer

3 days ago

Bangalore, India VRR Life Sciences Full time

Job Title: CSV Executive Location: Bangalore Experience: 2-4 years Industry: Pharmaceutical / Biotechnology / Lifesciences Key Responsibilities: Perform validation activities for Gx P computerized systems (planning, risk assessment, URS, IQ, OQ, PQ, summary reports) Prepare and review validation documentation in line with 21 CFR Part 11, EU Annex 11, and other regulatory guidelines Conduct impact assessments and periodic reviews for existing validated systems Support audits and inspections by presenting CSV documentation and processes Collaborate with QA, IT, and business users to ensure validation deliverables are met within timelines Guide project teams on validation requirements and risk-based approaches Ensure data integrity compliance across systems and processes Key Requirements: 2-4 years of hands-on experience in computer system validation within pharmaceutical, biotech, or life-sciences industries Strong knowledge of Gx P regulations, 21 CFR Part 11, EU Annex 11, and data integrity requirements Excellent documentation and communication skills Ability to work independently and in cross-functional teams

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