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Manager QA Validation
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Full-time
- Provide technical leadership and manage a team for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with cGxP, regulatory requirements and industry trends.
- Coach and mentor the team by proactively working with them on their performance and development for the professional growth within the organization.
- Essential Duties and Responsibilities include, but are not limited to, the following:Strong knowledge and understanding of equipment used for QC analysis and operations.
- Strong background and familiar with site change control, risk management and data integrity initiatives/programs.
- Previous experience as SME in highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits.
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