- Advising on the translation of GDP-, GMP- and customer requirements that need to be integrated in the operational processes. Ensure the incorporation of such requirements in the procedures and instructions and provide training when necessary.
- Follow-up of Quality-KPI’s.
- Review and alignment of Quality Technical Agreements with customers as well as with suppliers.
- Support and evaluate the investigation reports, impact assessments and defined CAPA’s, related to customer complaints and internal deviations; incl. follow-up of on-time closure of CAPA’s.
- Review and approve the registrations related to the temperature control program, pest control program and cleaning control program.
- Coordination of changes according the change control process.
- Coordination of risk assessment exercises.
- Performing of internal and supplier audits; coordination of external audits.
Translation, Audit Coordination, Customer complaints, GMP, Industrial, Impact Assessment, Pest control, Risk Analysis, Change Management, External Audit, Closures, Control Temperature, Change Control, Quality assurance, Provide Training, CAPA, Investigations, Coordination, Process control