Computer Systems Validation Specialist

22 hours ago


Agra, Uttar Pradesh, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 25,00,000

Professionals in the field of Validation Engineering are tasked with ensuring that computer systems and equipment meet strict quality standards.

Job Title: Validation Engineer

Mandatory Skills:

  • Hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
  • Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Experience in EDMS (Electronic Document Management system) & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.

Responsibilities:

  1. Develop clear, concise, and timely written reports.
  2. Excellent written communication skills.
  3. Ability to work on complex projects with general direction and minimal guidance.
  4. Handle multiple projects and meet deadlines.
  5. Manage priorities and workflow.


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