Senior Validation Engineer

5 days ago

Malappuram, Kerala, India beBeeComputerSystemValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title

Computer System Validation

Description

Our client is a leading software giant with over 11 billion dollars revenue, global workforce of 240000 employees, and presence in 60+ countries. They deliver end-to-end technology, consulting, and business process services to clients across the globe.

As a Computer System Validation Engineer, you will be responsible for validating computer systems and ensuring compliance with regulatory requirements.

The ideal candidate will have a bachelor's degree in a related field and at least 5 years of experience in computer system validation or quality compliance in a FDA-regulated industry.

You will be expected to possess strong knowledge of fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.

In addition, you should have hands-on experience in EDMS (Electronic Document Management system) & Test Management tools, as well as an understanding of FDA's recent guidance on transition of CSV to CSA.

Key responsibilities will include developing clear, concise, and timely oral and written reports, working on complex projects with general direction and minimal guidance, and managing priorities and workflow.

Required Skills and Qualifications
  • Bachelor's degree in a related field or equivalent.
  • 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.
  • Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.
Benefits

As a valued member of our team, you will enjoy a range of benefits including competitive salary, comprehensive health insurance, retirement plan, and paid time off.

Additionally, you will have opportunities for professional growth and development, as well as access to cutting-edge technology and resources.

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