Experienced Computer System Validation Specialist Wanted

2 days ago


Madurai, Tamil Nadu, India beBeeComputerSystemValidation Full time ₹ 17,56,250 - ₹ 25,12,500
Job Description

We are seeking a highly skilled and experienced Computer System Validation Engineer to join our team. This is an exciting opportunity for individuals who want to work in a dynamic and innovative environment.

In this role, you will be responsible for ensuring that our company's computer systems meet the highest standards of quality and compliance. You will work closely with cross-functional teams to design, implement, and maintain system validation plans and protocols.

Your primary focus will be on validating computer systems used in FDA-regulated industries such as medical devices, pharmaceuticals, and life sciences. You will have hands-on experience in EDMS (Electronic Document Management system) and Test Management tools.

You will also have a strong understanding of fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards. Additionally, you will be able to develop clear, concise, and timely oral and written reports.

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
  • Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs
  • Hands-on experience in EDMS & Test Management tools
  • Understanding of FDA's recent guidance on transition of CSV to CSA

Benefits

  • Opportunity to work with a top software giant in India
  • Global work force of 240000 employees
  • Presence in 60+ countries
  • Publicly traded company



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