Quality Assurance and Release Officer
Location: Haarlem area
Duration: 1year (with possible extension)
Language: Dutch and English
Start date: As soon as possible
The Quality Assurance department ensures that all the products are produced, processed, tested, packed, stored and distributed according to very high quality standards. and the applicable rules and laws. By creating close collaboration between our in-house manufacturing facilities and external partners and suppliers, we ensure a global manufacturing network committed to providing validated and reliable delivery to customers and patients worldwide.
About the Job
As Quality Assurance and Release Officer you are responsible for checking and securing the general cGMP compliance of our production location in Haarlem, suppliers and contract laboratories and will be in daily contact with QP's, on-site planners and Regulatory Affairs departments worldwide and you are mainly involved in operational support.
Reporting to the Manager Quality,
your responsibilities include:
- Checking the of production documentation and preparing the release of bulk and packaged products by the Qualified Person (QP)
- Participate in the introduction of new products. Within these projects you are responsible for the quality aspects.
- Review and authorize GMP documents, such as SOPs and other documents under change control;
- Supporting on-site planners in introducing changes to the product portfolio, such as master data management and creation;
- Review and approval of artwork, component Bill of Materials and bulk Bill of Materials;
- Regulatory compliance activities, such as managing the Registered Country Table and preparing certificates of analysis;
- MBO level 4 or HBO diploma in a pharmaceutical, life sciences, process engineering or chemical background
- At least 2 to 3 years of relevant work experience in the field of quality in a GMP environment;
- Experience with (setting up) SAP, LIMS and Trackwise is an advantage;
- Experience with packaging technology is a plus;
- Good communication skills in both word and writing in Dutch and English.
For this role an EU passport or (search year) VISA for Europe is required. No Intercontinental sponsorship possible. Are you ready to take a new step in your career? If you are interested or have any questions, Please reach out to me by applying to this vacancy