CSV Engineer

3 days ago

Bengaluru, Karnataka, 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 GxP 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 GxP 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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