Pharmaceutical Quality Systems Lead

2 weeks ago


India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

Job Title: Functional Testing Specialist

This role involves leading validation and configuration efforts for pharmaceutical quality systems, ensuring delivery of high-quality, compliant systems in life sciences.

  • 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.

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.

What We Offer:

  • A dynamic and collaborative work environment.
  • Ongoing training and professional development opportunities.
  • A competitive compensation package.


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