Validation Assurance Specialist

24 hours ago

Jodhpur, Rajasthan, India beBeevalidation Full time ₹ 25,00,000 - ₹ 35,00,000

We are seeking a seasoned Validation Assurance Specialist to join our team. This role will be responsible for ensuring the integrity of our computer systems and processes.

Required Skills and Qualifications:

  • Bachelor's degree in a related field or equivalent.
  • 5-8 years 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.

Benefits:

  • Opportunity to work on complex projects with general direction and minimal guidance.
  • Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
  • 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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