• Industrial Pharmacist, Pharmacist, Bio-Engineer or Industrial Engineer
  
• Experience in a QA position
  
• Dutch or French + English
  
  
  

As a QA specialist you will support the efficient, qualitative and compliant storage- and distribution processes of pharmaceutical and healthcare products and coordinate the implementation, monitoring, execution and improvement of quality-related aspects in the operational processes, in line with regulatory and customer requirements.
Your main task will be 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.
Above this you will report and follow-up of Quality-KPI's and review/align Quality Technical Agreements with customers as well as with suppliers.
Another task is to 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.
You will 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 and coordination of risk assessment exercises will also be part of the job.
You will perform internal and supplier audits; coordination of external audits.
Finally you will execute operational quality-tasks: local release, Disposition Statements, returned goods handling, stock status changes, Quality Dossiers of reworks, administrative handling of controlled drugs, …