Senior QA Engineer

3 days ago

Pune, Maharashtra, India beBeeValidation Full time ₹ 10,00,000 - ₹ 20,00,000

About our organization:

We are a global company providing information technology, consulting and business process services. Our team delivers cloud computing, computer security, digital transformation, artificial intelligence, robotics, data analytics and other technologies.

Job Role

You will ensure the quality and compliance of our systems and processes. Your main focus is on validating computer systems in FDA-regulated industries like medical devices, pharmaceuticals and life sciences.

  • Mandatory Skills:
  • 5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
  • Familiarity with fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • In-depth 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.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.
  • Able to develop clear, concise and timely oral and written reports. Excellent written and oral communication skills.
  • Able to work on complex projects with general direction and minimal guidance.
  • Able to handle multiple projects and meet deadlines.
  • Able to manage priorities and workflow. Versatility, flexibility and a willingness to work within constantly changing priorities with enthusiasm.

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