QA Specialist GDP/GMP
About DHL Pharma Logistics:
Our warehouse receives drug products from our clients which are distributed to more than 90 countries in the world. We are also managing the detail distribution of these drug products to wholesalers, pharmacies and hospitals in Belgium, the Netherlands and Luxembourg.
Primary Purpose of the Role
·Supporting the efficient, qualitative and compliant storage- and distribution processes of pharmaceutical and healthcare products.
·Coordinate the implementation, monitoring, execution and improvement of quality-related aspects in the operational processes, in line with regulatory and customer requirements.
Main Tasks of the QA Specialists Team:
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.
Reporting and 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.
Execution of operational quality-tasks: local release, Disposition Statements, returned goods handling, stock status changes, Quality Dossiers of reworks, administrative handling of controlled drugs, …
Industrial Pharmacist, Pharmacist, Bio-Engineer or Industrial Engineer.
Minimum 5 years of experience in a QA-position, preferably in the Pharmaceutical-related Industry
Operational knowledge of GDP- and GMP-regulations and Quality Management Systems
Strong communication and coordination skills to bring together different stakeholders, to make clear agreements, to make proper adjustments when required, …
Strong analytical skills to review and evaluate reports, registrations, processes, …
Knows to combine high accuracy with urgency and changing priorities
Problem-solver, prepared to take responsibility and ownership
Excellent written and spoken Dutch and English, customer oriented
Be able to work individually and independently, in combination with being a teamplayer as well
Zahlen und Fakten
Pharma Logistics NV