Senior Validation Specialist

4 days ago


Kolkata, West Bengal, India beBeeCompliance Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

About Our Role:

We are seeking a highly skilled and experienced Validation Engineer to join our team.

  • Mandatory Skills:
  • Proven experience in computer system validation, quality compliance and GxP systems within FDA-regulated industries.
  • Knowledge of cGMP concepts and regulations including QSR, 21 CFR Part 820, 21 CFR Part 11, ISO 9001 Standards and FDA guidance on CSV to CSA transition.
  • Strong understanding of FDA-regulated manufacturing processes, process validation, equipment validation and GMPs.
  • Hands-on experience with electronic document management systems (EDMS) and test management tools.
  • Ability to work effectively with complex projects, prioritize tasks and meet deadlines.

Key Responsibilities:

  1. Develop clear, concise and timely reports for various stakeholders.
  2. Work independently on complex projects with minimal supervision.
  3. Manage multiple projects simultaneously and ensure timely delivery.
  4. Utilize prioritization and workflow management skills to achieve project goals.


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