Validating Critical Systems

2 days ago

Bengaluru, Karnataka, India beBeeDataValidation Full time ₹ 9,00,000 - ₹ 12,00,000

Job Title: Data Validation Specialist

Bangalore Location

2-4 Years of Experience

Pharmaceutical / Biotechnology / Lifesciences Industry

Key Responsibilities:

  • Perform validation activities for GxP computerized systems including planning, risk assessment, URS, IQ, OQ, PQ and 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:

  • 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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