
Quality Assurance System Validator
2 days ago
This role involves leading validation efforts for Trackwise, Labware LIMS, and Documentum D2 platforms, ensuring delivery of high-quality systems in life sciences.
- Develop and execute test strategies, protocols, and test scripts to ensure GxP, 21 CFR Part 11, and overall regulatory compliance.
- Collaborate with QA/CSV/business teams to ensure accurate system validation, review SOPs, system documentation, and create traceability matrices.
Requirements:
- 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) and solid understanding of GAMP 5, FDA 21 CFR Part 11, and CSV best practices.
Benefits:
- Excellent communication and documentation skills.
- Experience working with global cross-functional teams is a plus.
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