Trackwise/LIMS/D2 Functional Testing Lead

2 weeks ago

India Dminds Solutions Inc. Full time

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 (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

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