Chief Validation Specialist

4 days ago


Allahabad, Uttar Pradesh, India beBeeComputerSystemValidation Full time ₹ 1,62,50,000 - ₹ 2,52,50,000

As a professional in the field of Computer System Validation, your primary responsibility will be to ensure the quality and compliance of computer systems within the Medical Device/Pharma/Life Sciences industry.

Job Overview

This role requires a strong understanding of GxP system requirements and the ability to validate computer systems to meet these standards. Additionally, you will be responsible for developing and maintaining EDMS (Electronic Document Management System) & Test Management tools.

Key Responsibilities:
  • Validate computer systems to ensure they meet regulatory requirements.
  • Develop and maintain Electronic Document Management Systems and Test Management tools.
  • Stay up-to-date with FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Collaborate with cross-functional teams to resolve complex project issues.
  • Effectively communicate through written and oral reports.
Requirements:
  • Bachelor's degree in a related field or equivalent.
  • 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry.
  • Strong knowledge of cGMP concepts and FDA/EMA regulations.
  • Hands-on experience in EDMS & Test Management tools.


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