Flexible depending on experience
about 1 year ago
My leading biotechnology client is looking to hire a contract QP for an initial 9 month period to join their newly formed QP team, as they look to move away from contract manufacturing, and taking things internally. They are looking for someone with a strong background as a Qualified Person, to set up the Quality Management System (QMS) from scratch, putting procedures in place and dealing with the regulatory authorities to drive towards license
Other responsibilities include:
- Support site QA head in setting up a robust Quality Management System
- Participating and leading inspections and audits to ensure full compliance
- Being the license holder
- Review all submissions (CMC) to regulatory authorities concerning the product.
- Final sign off and batch release.
- QP Qualified with the Dutch authorities
- Dutch speaking is a preference but not a must.
- Ideally experience working with solid dosage/API and sterile finished goods.
- A self starter who has the ability to work independently and be the final decision maker around issues.
If this is something that you would be interesting in discussing further, then please apply now and one of our consultants will get in touch!