Computer System Validation Specialist

2 days ago

Mysore, Karnataka, India beBeeSystemValidation Full time ₹ 20,00,000 - ₹ 25,00,000

Our organization seeks a seasoned Computer System Validation Specialist to spearhead our validation initiatives.

Job Overview:

We require an experienced professional with a strong background in computer system validation, EDMS, and the medical domain. The successful candidate will have a bachelor's degree in a related field and at least 5 years of hands-on experience in computer system validation/quality compliance in a FDA-regulated industry.

  • Fundamental Knowledge: cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Key Skills: Strong knowledge of FDA-regulated manufacturing processes, process validation, computer and equipment validation, and GMPs. Hands-on experience in EDMS & Test Management tools.
  • Recent Guidance: Understanding of FDA's recent guidance on the transition of CSV to CSA.
  • Communication: Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.

What We Offer:

A dynamic work environment with opportunities for growth and development. A competitive salary package and benefits that reflect your skills and experience.

About Us:

Our company is a global organization with a presence in over 60 countries, delivering end-to-end technology, consulting, and business process services to clients worldwide.

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