with hands-on experience in pharmaceutical quality systems, including
Trackwise
,
Labware LIMS
, and
Documentum D2
. The ideal candidate will have a strong background in validation, configuration, and compliance-driven testing in a regulated (GxP) environment.
This role involves collaboration with cross-functional teams across QA, CSV, and business units, ensuring delivery of high-quality, compliant systems in life sciences.
Key Responsibilities
Lead validation and configuration efforts for Trackwise, Labware LIMS, and Documentum D2 platforms
Develop and execute test strategies, protocols, and test scripts
Ensure GxP, 21 CFR Part 11, and overall regulatory compliance
Conduct impact assessments and lead UAT support and defect triage
Review SOPs, system documentation, and create traceability matrices
Collaborate with QA/CSV/business teams to ensure accurate system validation
Qualifications
5+ years of experience in QA/QC systems in the life sciences/pharmaceutical domain
Proficiency in Trackwise, Labware LIMS, and Documentum D2 platforms
Strong experience in validation lifecycle documentation (IQ, OQ, PQ)
Solid understanding of GAMP 5, FDA 21 CFR Part 11, and CSV best practices
Excellent communication and documentation skills
Experience working with global cross-functional teams is a plus
Keywords
Trackwise, LIMS, Labware, Documentum D2, Functional Testing, Pharma QA, CSV, GxP, Validation, Software Testing, 21 CFR Part 11, GAMP5, UAT, Life Sciences, Remote QA Jobs, Bengaluru Jobs
Job Type: Full-time
Pay: ₹1,200,000.00 - ₹1,600,000.00 per year
Benefits:
Provident Fund
* Work from home
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