Job Description

  • BE degree or equivalent work experience in Computer Science, Biology, Biomedical or related field.
  • Over all 5+ Years of experience and at least 2+ years of Computer System Validation/ Product Software Validation testing experience in a regulated environment.
  • Understanding of US FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and ISO regulations. e.g., design controls, risk management, and software validation.
  • Prepare and manage key validation documents, including Validation Master Plans (VMP), risk assessments, protocols, test plans, and reports. Ensure that these documents are compliant with internal and external standards.
  • Design, document, and execute detailed test cases that demonstrate that the system meets the validation requirements. This includes functional testing, integration testing, and user acceptance testing (UAT).
  • Record, report, and verify software defects to accurately depict the software requirements also work closely with ...

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