System Validation Specialist

3 days ago

Jaipur, Rajasthan, India beBeeFunctionalTesting Full time ₹ 15,00,000 - ₹ 20,00,000
Lead Functional Testing Expert

Job Title: Lead Functional Testing Expert

Location: Remote

Expect to Join: 15-30 days

  • We seek a highly skilled Functional Testing Lead with extensive hands-on experience in pharmaceutical quality systems, encompassing Trackwise, Labware LIMS, and Documentum D2.
  • The ideal candidate will possess a robust background in validation, configuration, and compliance-driven testing within regulated environments (GxP).
  • This role involves close collaboration with cross-functional teams across QA, CSV, and business units to ensure high-quality, compliant systems are delivered in life sciences.

Key Responsibilities:

  • Oversee 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:

  • At least 5 years of experience in QA/QC systems within 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 advantageous.

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