
Pharmaceutical System Validation Specialist
2 weeks ago
Job Description:
- We are seeking an experienced Pharmaceutical System Validation Specialist with in-depth knowledge of quality systems, including Trackwise, Labware LIMS, and Documentum D2.
- The ideal candidate will have a strong background in validation, configuration, and compliance-driven testing in regulated environments.
- This role involves collaboration with cross-functional teams to ensure delivery of high-quality, compliant systems in life sciences.
Key Responsibilities:
- Lead validation and configuration efforts for Trackwise, Labware LIMS, and Documentum D2 platforms.
- Develop and execute test strategies, protocols, and test scripts.
- Ensure regulatory compliance, including GxP and 21 CFR Part 11.
- 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.
Benefits:
This is an excellent opportunity for a skilled professional to join our team and contribute to the development of high-quality systems.
How to Apply:
Please submit your application, including your resume and cover letter, to us via email. We look forward to hearing from you
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