Expert System Validator

2 days ago


Aurangabad, Maharashtra, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000
System Validation Expert

About Us:

We are seeking a System Validation Expert to join our team. The ideal candidate will have experience in Computer System Validation and Quality Compliance.

  • Job Title: System Validation Expert
  • Job Locations: Remote/On-Site
  • Experience: 5-10 Yrs
  • Employment Type: Full time
  • Notice Period: Immediate joiner - 30Days (Notice period)

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.
  • Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.
  • Ability to develop clear, concise, and timely oral and written reports. 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. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.


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