10 months ago
Quality Assurance Specialist
We are currently working with one of the largest biopharmaceutical companies globally who have revenues of $22bn and operations in several continents, who are looking to expend their QA team and looking for skilled professionals with experience of monitoring GMP and GPP compliance.
Main duties include:
- Maintaining the Wholesale Permit in Accordance with the Responsible Person (RP) for the local organization according to the European Good Distribution Practice
- Compliance with the National Good Manufacturing Practices (GMP), the Counterfeit Medicines Directive and the Sales and Distribution (GDP) Directive Monitoring of sales processes and maintaining product quality throughout the distribution chain (eg customer qualification)
- Implementation and monitoring of the quality management system and maintenance and follow-up of all required documents
- Implementation of QA training to the wider team
- Provide assistance to the responsible person when conducting audits and inspections
- Information of all internal and external stakeholders about suspicious events or quality
issues that are related to the distribution rights for wholesalers Coordination and implementation of recalls and, if necessary, contacting the health authority
- Close cooperation with various interfaces at local level (eg Pricing & Logistics, approval, drug safety, medical information) as well as at regional level (supply chain, quality assurance, customer service in Breda, Holland) or global level (quality assurance)
- Adherence to additional tasks required by national legislation for certain products Requirements
- Degree in related Scientific or Pharmaceutical field
- Ideally at least 3 years relevant work experience, preferably with knowledge / experience in good manufacturing practice (GMP) and/or GDP
- Excellent knowledge of quality management systems (QMS)
- Very good French and English skills (spoken and written)
- The ability to solve problems and think outside of the box.
If you are interested in this opportunity, please apply now for more details!