
Functional Testing Professional
4 days ago
Job Description:
- We are seeking a skilled professional with hands-on experience in pharmaceutical quality systems, including Trackwise and Labware LIMS.
- The ideal candidate will have a strong background in validation, configuration, and compliance-driven testing in a regulated environment.
- This role involves collaboration with cross-functional teams across QA, CSV, and business units to ensure delivery of high-quality, compliant systems in life sciences.
Key Responsibilities:
- Lead validation and configuration efforts for Trackwise and Labware LIMS platforms
- Develop and execute test strategies, protocols, and test scripts
- Ensure regulatory compliance and conduct impact assessments
- Review system documentation and create traceability matrices
- Collaborate with QA/CSV/business teams to ensure accurate system validation
Qualifications:
- 5+ years of experience in QA/QC systems in the life sciences/pharmaceutical domain
- Proficiency in Trackwise and Labware LIMS platforms
- Strong experience in validation lifecycle documentation (IQ, OQ, PQ)
- Solid understanding of GAMP 5 and FDA 21 CFR Part 11 best practices
- Excellent communication and documentation skills
- Experience working with global cross-functional teams is a plus
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