Job Description
Specialist Quality Line
Manage all aspect of quality on the product line
Lead Quality Emergency situation (QA crisis management) for the scope of responsibility, with support of other departments.
Key responsibilities
- Ensure compliance to all work instructions in place on the manufacturing line and perform regularly GMP audits to related topics Quality documentation, Work instruction, Calibration, Records.
- Manage Quality hold related to the scope of responsibility, in collaboration with QH Specialist. Lead Root Cause analysis to perform investigation on any new quality defects or non-conformities raised during MRB.
- Open non-conformity NC in case of reoccurrence of significant quality issues (risk / occurrence / detection) as per standard in place. Review risk analysis and ensure PFMEA are up to date.
- Manage CAPA related to operational quality issue.
- Create Quality dashboard in collaboration ...