Up to 90,000 € per year
6 months ago
Qualified Person (QP)
We are currently working with a leading global biotech organisation, based in the Amsterdam area, who are looking to hire a Qualified Person (QP) to join their expanding and growing team as they look to establish an experienced and highly skilled work force. The successful candidate will be responsible for helping to develop and implement the QP processes for product release and disposition.
Other responsibilities include:
- Support site QA head in the implementation of Supplier Quality oversight program in EU. QP must be involved in all critical suppliers, including contract manufacturers and contract test laboratories.
- Ensure that the marketing Authorization and Manufacturing Authorization or IMP Authorization requirements for the products have been met for the patient batch concerned.
- Support site QA head in setting up a robust Quality Management System, meeting EU standards, in line with QMS. The objective is to obtain a GMP license for the Kite new building for its EU GMP activities.
- Review all submissions (CMC) to regulatory authorities concerning the product (IMP/MP).
- Build relationships with all other functional teams
- Registered QP in the Netherlands.
- Minimum 3 years’ experience within Pharmaceutical, Biotech or biologics environment.
- Degree Qualified within a related discipline.
- Experience of product release with in depth knowledge of GMP
If this is something of interest and you are keen to discuss further, please apply now and one of our consultants will get in touch!