- Represent the quality function in the approval and closing of Deviations :
- Act as Quality Representative to evaluate, investigate and approve Deviation reports.
- Represent the quality function in the approval and closing of Change Control :
- Act as a Quality Representative to review and approve Change Request.
- Participate to FMEA if requested.
- Data and trends analysis
- Act as a quality link on the floor to support adequate quality systems deployment and participate to TIER.
- Support any quality decision in coordination with Manufacturing. Provide support and expertise in all quality related issues.
- Perform GMP Gemba during routine operations to ensure the application of the cGxP’s, the compliance to the procedures, and all the aspects linked to the safety, the reliability and the consistency of the operations.
- Participate to continuous improvement projects (Yellow belt, DMAIC, …).
- Provide support for external audits
BEL - Lessines