Scientific Technical Specialist - I
Quality Assurance Officer
Our client is a one of the biggest innovative pharmaceutical companies in the Netherlands. They are specialized in vaccines, biological therapies and medicines.
Within this role, you are responsible for checking general cGMP compliance of our production location in Haarlem, suppliers and contract laboratories. These checks are carried out on the basis of internal guidelines, procedures, experience and interpretation of general laws and regulations. As a Quality Assurance Officer you participate in multidisciplinary projects as a representative of Quality.
- Reviewing, advising and checking validation projects within the site. Within these projects you are the representative of Quality.
- Guaranteeing the validated status of cGxP processes, subsystems and suppliers.
- Fulfilling the Quality role in technical projects, both process and IT.
- Support and monitor the handling of deviations.
- Checking and authorizing GMP documents, such as SOP's qualification / validation documentation and change control documentation.
- Supporting CoEs and IPTs in implementing changes to guidelines.
- Monitoring and auditing CoE and IPT activities with regard to compliance and taking the necessary actions. Performing audits as an internal Lead Auditor and supervising external audits.
- Review and approve quality agreements with suppliers.
- Coordinate and communicate complaints to exclusive suppliers of our production location and follow up improvements at the same suppliers.
- Bachelor in life sciences
- 3 years of relevant experience
- Experience with GMP/GDP;
- Experience with packaging technology is preferred
- Dutch and English