Trackwise/LIMS/D2 Functional Testing Lead

4 days ago

Madurai, Tamil Nadu, India Dminds Solutions Inc. Full time ₹ 1,50,00,000 - ₹ 2,00,00,000 per year

Job Title: Trackwise/LIMS/D2 Functional Testing Lead Location: Remote (India)Expect to Join: 15-30 days Job 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 (Gx P) 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 Gx P, 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 Qualifications5+ 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

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