Test Engineering Lead

2 weeks ago


Hubli, Karnataka, India beBeeCompliance Full time ₹ 14,00,000 - ₹ 21,00,000

Job Title: Test Engineering Lead

Location: Remote Work Opportunity

Job Description:

  • We are seeking a skilled professional to lead testing efforts for 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 regulated environments.
  • This role involves collaboration with cross-functional teams across QA, CSV, and business units to ensure 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

Requirements:

  • 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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