GxP Functional Testing

Bahwan CyberTek

3 - 7 years

10 - 20 Lacs

pune chennai bengaluru

Posted:2 days ago| Platform:

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Skills Required

trackwise gxp fda csv cfr

Work Mode

Hybrid

Job Type

Full Time

Job Description

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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