Highly Skilled Quality Systems Tester

2 days ago

India beBeeFunctional Full time ₹ 15,00,000 - ₹ 20,00,000

**Job Title:** Functional Testing Lead

**Location:** Remote

**About the Role:

  • We are seeking a seasoned professional 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 environment.
  • This role involves collaboration with cross-functional teams 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 regulatory compliance, 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.

**Required Skills and 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.

**Benefits:

No benefits are mentioned as they should be related to company specifics which you provided us with.

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