Pharmaceutical System Validation Lead

2 days ago


Anand, Gujarat, India beBeeQuality Full time ₹ 1,20,00,000 - ₹ 1,80,00,000
Senior Quality Assurance Specialist

We are seeking a highly skilled and experienced quality assurance professional to lead the validation and configuration of pharmaceutical quality systems.

This role involves collaboration with cross-functional teams to ensure delivery of high-quality, compliant systems in life sciences.

Key Responsibilities
  • Lead validation 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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