QA Engineer

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:

• 3-6 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.