Senior Validation Specialist

4 days ago

Nashik, Maharashtra, India beBeeComputerSystemValidator Full time ₹ 30,00,000 - ₹ 35,00,000
About Our Company

We are a leading global software giant delivering end-to-end technology consulting and business process services to clients worldwide.

Our ideal candidate for this role is a detail-oriented individual with a strong background in computer system validation and quality compliance. They will be responsible for ensuring that our systems meet the required standards and regulations.

The successful candidate will have hands-on experience with EDMS and Test Management tools as well as a solid understanding of cGMP concepts and FDA/EMA regulations. They will also possess excellent written and oral communication skills with the ability to develop clear and concise reports and presentations.

In this role you will work on complex projects with minimal guidance handling multiple tasks and meeting deadlines. You will need to be versatile flexible and able to adapt to changing priorities with enthusiasm.

Mandatory Requirements:

  • Bachelor's degree in a related field or equivalent.
  • 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences).
  • 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.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.

Required Education and Training:

  • Bachelor's degree in a related field or equivalent.

Preferred Skills and Experience:

  • Hands-on experience with Microsoft Word Excel PowerPoint & Visio.
  • Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.

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