Senior Systems Validation Specialist

2 days ago


Thiruvananthapuram, Kerala, India beBeeValidation Full time ₹ 18,00,000 - ₹ 25,00,000

Job Description:

We are seeking an experienced Validation Engineer to join our team. The ideal candidate will have strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.

The candidate should also have hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.


Required Skills and Qualifications:

  • Fundamental knowledge of cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong understanding of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.
  • Excellent written and oral communication skills.
  • Ability to work on complex projects with general direction and minimal guidance.
  • Ability to handle multiple projects and meet deadlines.
  • Ability to manage priorities and workflow.

Benefits:

Our company offers a challenging and rewarding work environment with opportunities for growth and development.

We are an equal opportunities employer and welcome applications from all qualified candidates.



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