
Senior Pharmaceutical Quality Systems Specialist
1 week ago
Job Title: Functional Testing Lead
Description:
- We are seeking a senior professional to lead validation and configuration efforts for Trackwise, Labware LIMS, and Documentum D2 platforms.
- The ideal candidate will have hands-on experience in pharmaceutical quality systems and 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.
Responsibilities:
- Develop and execute test strategies, protocols, and test scripts for GxP-compliant systems.
- Ensure regulatory compliance with 21 CFR Part 11 and overall GxP regulations.
- Conduct impact assessments and lead UAT support and defect triage for Trackwise, Labware LIMS, and Documentum D2 platforms.
- Review SOPs, system documentation, and create traceability matrices for quality assurance.
- Collaborate with QA/CSV/business teams to ensure accurate system validation and deliver high-quality results.
Qualifications:
- At least 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 highly desirable.
About the Role:
This is an exciting opportunity to join our organization and contribute to the development of high-quality systems in life sciences. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.
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