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1 week ago

Delhi, Delhi, India Dminds Solutions Inc. Full time

Job Title: Trackwise/LIMS/D2 Functional Testing LeadLocation: Remote (India)Expect to Join: 15-30 daysJob Description:We are seeking a Functional Testing Lead 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 ResponsibilitiesLead validation and configuration efforts for Trackwise, Labware LIMS, and Documentum D2 platformsDevelop and execute test strategies, protocols, and test scriptsEnsure GxP, 21 CFR Part 11, and overall regulatory complianceConduct impact assessments and lead UAT support and defect triageReview SOPs, system documentation, and create traceability matricesCollaborate with QA/CSV/business teams to ensure accurate system validationQualifications5+ years of experience in QA/QC systems in the life sciences/pharmaceutical domainProficiency in Trackwise, Labware LIMS, and Documentum D2 platformsStrong experience in validation lifecycle documentation (IQ, OQ, PQ)Solid understanding of GAMP 5, FDA 21 CFR Part 11, and CSV best practicesExcellent communication and documentation skillsExperience working with global cross-functional teams is a plus

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