IT Validation

5 days ago

Bengaluru, Karnataka, India UST Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Key Responsibilities:

  • Develop and execute Validation Plans, Test Protocols (IQ, OQ, PQ), and Traceability Matrices for IT systems.
  • Conduct risk assessments and determine validation strategy based on system impact and regulatory requirements.
  • Prepare and maintain Validation Documentation (User Requirements Specifications, Functional Specs, Test Scripts, Reports, etc.).
  • Perform Verification testing (manual and automated) to ensure system functionality aligns with specified requirements.
  • Ensure compliance with industry standards such as 21 CFR Part 11, Annex 11, GAMP 5, and ISO 13485 (if applicable).
  • Collaborate with IT, QA, and business stakeholders to support Computer System Validation (CSV) efforts across the lifecycle.
  • Participate in audits and inspections by internal/external auditors or regulatory bodies.
  • Track and resolve deviations, bugs, or non-conformities during the validation lifecycle.
  • Maintain validation records and change control documentation.

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