- Lead the development, deployment, and continuous improvement of the QRM program, including procedures, templates, and tools.
- Facilitate cross-functional risk assessments using methodologies such as hazard analysis and FMEA.
- Serve as a trained backup for Document Control and GxP Training activities, maintaining inspection-ready records.
- Collaborate across functions to promote a quality culture and provide risk-based guidance.
- Support eQMS administration, optimization, and validation of GxP computerized systems.
- Maintain audit-ready QMS documentation and support regulatory inspection preparation and response.
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