- Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
- Certifies batches for sale or supply in compliance with regulations.
- Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
- Attends and participates Event Review, Quality Systems Review and Site QP Meetings
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
- Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs). Proficient in application of QA principles, concepts, industry practices, and standards.
- Demonstrates ability to effectively manage multiple projects/priorities
- Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
