
Pharmaceutical System Validation Lead
2 days ago
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
- 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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