The QA System & Compliance officer is acting as an SME for leading several quality systems. The QA System & Compliance officer will work on the improvement of the QMS and ensure its appropriate level of compliance. You will support the Quality Responsible person with customer Audits and inspections.
- Compile and analyze different data sets related to our products in order to write and review Annual Product Reviews
- Perform compliance gap assessments in cooperation with all departments and coordinate associated CAPAs.
- Perform QA review of CAPAs
- Management of quality KPI (metrics, reporting, pareto analysis)
- Participate in Quality Oversight by execution of shop-floor spot-checks or as a qualified auditor (if requested).
- Coordinate continuous quality improvement projects.
- Act as a support for the team by doing backup activities such as audit/inspection preparation, data analysis, TrackWise admin and other supportive activities to the team objectives.
- University degree, preferably scientific degree such as Pharmacist, Engineer, or equivalent. Or equivalent by experience.
- Preferably with experience in a quality/GMP environment
- Fluent in French and English, Dutch is a plus