
Senior Life Sciences Validation Professional
3 days ago
We are seeking an experienced Lead Validation and Compliance Specialist to play a crucial role in ensuring the delivery of high-quality, compliant systems in life sciences.
The ideal candidate will have a strong background in validation, configuration, and compliance-driven testing in a regulated environment. Key responsibilities include leading cross-functional teams to ensure accurate system validation, developing and executing test strategies, protocols, and test scripts, and ensuring overall regulatory compliance.
- Develop and execute comprehensive test plans, identifying and addressing potential risks and gaps.
- Collaborate with cross-functional teams to integrate validation efforts, leveraging collective expertise to achieve optimal results.
- Stay up-to-date with emerging industry trends and regulations, applying knowledge to inform strategic decisions.
Qualifications include 5+ years of experience in QA/QC systems in the life sciences/pharmaceutical domain, proficiency in Trackwise, Labware LIMS, and Documentum D2 platforms, and solid understanding of GAMP 5, FDA 21 CFR Part 11, and CSV best practices.
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