System Assurance Specialist

5 days ago


Madurai, Tamil Nadu, India beBeeValidationEngineer Full time ₹ 20,00,000 - ₹ 25,00,000

About the Role:

As a Validation Engineer, you will be responsible for ensuring the quality and integrity of our systems and processes.

The ideal candidate will have 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.

Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards is required.

You will work closely with cross-functional teams to develop clear, concise, and timely oral and written reports.

Additionally, you will have hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.

Key Responsibilities:

  • Develop and implement validation strategies
  • Conduct thorough risk assessments and mitigation plans
  • Collaborate with cross-functional teams to ensure smooth project execution

Requirements:

  • Bachelor's degree in a related field or equivalent
  • 5-8 years of experience in Computer System Validation/Quality Compliance
  • Hands-on experience with Microsoft word, Excel, PowerPoint & Visio
  • Preferred skills include EDMS (Electronic Document Management system) & Test Management tools

Why Work with Us?

We offer a dynamic and supportive work environment that encourages growth and development.



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