GxP Functional Testing

8 hours ago

Bengaluru Chennai Pune, India Bahwan CyberTek Full time

We are looking for a TrackWise & GxP Tester with 3 to 6 years of experience to support testing activities in regulated life sciences environments. The role involves ensuring quality, compliance, and validation of systems aligned with GxP regulations.

Key Responsibilities:

  • Perform functional, regression, and UAT testing for TrackWise applications.
  • Ensure compliance with GxP, FDA, and 21 CFR Part 11 requirements.
  • Prepare and execute validation deliverables including Test Plans, Test Cases, RTM, and Test Summary Reports.
  • Review and support CSV (Computer System Validation) documentation.
  • Work closely with business, quality, and development teams to understand requirements and ensure compliant testing.
  • Identify, document, and track defects using test management tools.
  • Support audits and inspections by providing required testing and validation evidence.

Required Skills & Experience:

  • 36 years of experience in testing TrackWise applications.
  • Strong understanding of GxP regulations, FDA guidelines, and 21 CFR Part 11.
  • Hands-on experience with Computer System Validation (CSV).
  • Experience in SDLC/STLC within regulated environments.
  • Knowledge of defect management and test management tools.
  • Good communication and documentation skills.

Preferred Skills:

  • Experience in Life Sciences / Pharma / Healthcare domains.
  • Exposure to Agile or Waterfall methodologies.
  • ISTQB or similar certification is a plus.

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