Principal Computer System Validator

8 hours ago

Tiruppur, Tamil Nadu, India beBeeComputerSystemValidation Full time ₹ 1,41,03,024 - ₹ 2,41,05,168

Our organization requires a skilled Computer System Validation Specialist to ensure the integrity and quality of computer systems in regulated industries.

This role involves collaborating with cross-functional teams to develop and implement effective system validation strategies.

  • Bachelor's degree in a relevant field or equivalent is required.
  • A minimum of 5-8 years of experience in Computer System Validation/Quality Compliance in regulated industries, preferably in Medical Device/Pharma/Life Sciences, with a focus on GxP systems.
  • Familiarity with fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 standards is necessary.
  • Strong knowledge of regulated manufacturing processes, process validation, computer and equipment validation, and GMPs is essential.
  • Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools is required.
  • Understanding of recent guidance on transitioning CSV to CSA is beneficial.
  • Excellent written and oral communication skills are necessary for developing clear, concise reports.
  • Ability to work on complex projects with minimal guidance and manage priorities effectively.

Please note that this position requires strong analytical and problem-solving skills, as well as the ability to adapt to changing priorities and deadlines.

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