Life Sciences Quality Systems Expert

2 days ago


Varanasi, Uttar Pradesh, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

This is a role for an expert in life sciences quality systems.

The job involves leading cross-functional teams to ensure delivery of high-quality, compliant systems.

Key Responsibilities:

  • Validation and configuration of Trackwise, Labware LIMS, and Documentum D2 platforms
  • Test strategies, protocols, and test scripts development and execution
  • GxP, 21 CFR Part 11, and overall regulatory compliance
  • Impact assessments and UAT support
  • SOPs review, system documentation creation, and traceability matrices
  • Cross-functional team collaboration for accurate system validation

Qualifications:

  • 5+ years of QA/QC systems experience in the life sciences/pharmaceutical domain
  • Proficiency in Trackwise, Labware LIMS, and Documentum D2 platforms
  • Strong validation lifecycle documentation skills (IQ, OQ, PQ)
  • GAMP 5, FDA 21 CFR Part 11, and CSV best practices knowledge
  • Excellent communication and documentation skills
  • Global cross-functional team experience



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