System Validation Specialist

1 day ago

Kollam, Kerala, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,31,00,000

Our client is a global leader in software technology, with over $11.3 billion dollars revenue and a workforce of 240,000 employees worldwide. It delivers end-to-end technology, consulting, and business process services to clients across the globe, present in 60+ countries.

Seeking an experienced Validation Engineer with key responsibilities including:

  • Validating computer systems for FDA-regulated industries such as Medical Device/Pharma/Life Sciences.
  • 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.

The ideal candidate will have a Bachelor's degree in a related field or equivalent, 5-8 years of hands-on experience in Computer System Validation/Quality Compliance, and excellent written and oral communication skills.

Responsibilities include:

  • Validating computer systems for FDA-regulated industries such as Medical Device/Pharma/Life Sciences
  • 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

Key qualifications for this role include:

  • Bachelor's degree in a related field or equivalent
  • 5-8 years of hands-on experience in Computer System Validation/Quality Compliance
  • Excellent written and oral communication skills

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