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2 days ago
Job Title: Validation and Compliance Specialist
Job Description:We are seeking an experienced professional to lead validation and configuration efforts for Trackwise, Labware LIMS, and Documentum D2 platforms. The ideal candidate will have a strong background in GxP, 21 CFR Part 11, and regulatory compliance.
Main Responsibilities:- Lead validation and configuration efforts to ensure seamless system integration.
- Develop and execute test strategies, protocols, and test scripts to meet regulatory requirements.
- Conduct impact assessments and lead UAT support and defect triage to identify and resolve system issues promptly.
- Review SOPs, system documentation, and create traceability matrices to maintain accurate records and facilitate audits.
- 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, with a solid understanding of GAMP 5, FDA 21 CFR Part 11, and CSV best practices.
- Excellent communication and documentation skills, with experience working with global cross-functional teams.
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