Computer System Validation Specialist

1 day ago

Kottayam, Kerala, India beBeeCompliance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

We are seeking a skilled Computer System Validation Specialist to support our client's software development in India. The ideal candidate will have strong knowledge of FDA-regulated manufacturing processes, process validation, and computer system validation.

Key Responsibilities:
  • Bachelor's degree in a related field or equivalent experience
  • 5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a FDA-regulated industry with a focus on GxP systems
  • Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards

The successful candidate will be proficient in EDMS & Test Management tools, with an understanding of FDA's guidance on transition of CSV to CSA. Excellent written and oral communication skills are essential for this role.

This position requires the ability to work on complex projects with minimal guidance. Strong analytical and problem-solving skills are necessary for developing clear and concise reports.

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