System Validation Expert

2 days ago


Bellary, Karnataka, India beBeeValidation Full time US$ 1,40,000 - US$ 1,70,000

Our client is a software giant with a global workforce and delivers end-to-end technology, consulting, and business process services worldwide.

Job Title: Computer System Validation Engineer

You will be responsible for validating computer systems ensuring compliance with FDA regulations and industry standards.

Key Responsibilities:
  • Develop clear reports on system validation and quality compliance.
  • Collaborate with cross-functional teams to implement system validation and testing.
  • Conduct risk assessments and develop mitigation strategies for system vulnerabilities.
  • Stay up-to-date with FDA regulations and industry standards such as GxP cGMP QSR and ISO 9001.
  • Work on complex projects prioritizing tasks and meeting deadlines.

Strong knowledge of FDA-regulated manufacturing processes computer equipment validation and GMPs are required.

Requirements:
  • 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 understanding of EDMS and Test Management tools.
  • Ability to work effectively in a team environment.


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