Senior Validation Professional

2 days ago


Vellore, Tamil Nadu, India beBeeValidation Full time ₹ 15,00,000 - ₹ 25,00,000

About this role:

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

  • Mandatory Skills and Qualifications:
  • - 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a regulated industry with a focus on GxP systems.
  • - In-depth knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • - Strong understanding of regulated manufacturing processes, process validation, computer and equipment validation, and Good Manufacturing Practices (GMPs).
  • - Hands-on experience in Electronic Document Management systems (EDMS) & Test Management tools.
  • - Familiarity with recent FDA guidance on the transition from CSV to CSA.

The ideal candidate will possess excellent written and oral communication skills, be able to develop clear and concise reports, and work effectively on complex projects with minimal supervision. They must also be able to handle multiple priorities, meet deadlines, and demonstrate versatility, flexibility, and enthusiasm for changing project requirements.



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