100,000 € per year
over 1 year ago
Qualified Person (QP)
We are currently working with a leading biotechnology organisation based in the Netherlands, who are part of one of the biggest companies in the Life Science industry globally at the moment, with a large amount of investment and growth expected in the next few years. They are currently looking for a Senior QP, to join a newly formed team and be part of the growth of the team in the coming months.
They are looking for someone to join and be responsible for developing, the implementation and then overview the continued process for the product distribution for the organisation within the EMEA region.
Main responsibilities include:
- Support the site QA head in the implementation of wider quality systems and programs across the EU. The QP should be responsible for being involved in dealing with CMO’s and test laboratories.
- Review all submissions to the regulatory authorities for the products.
- Support the team during upcoming and ongoing inspections with regulatory agencies.
- Support the QA team in setting up the Quality Management System (QMS) in the EU, which will meet EU standards, with a plan to obtain a GMP licence.
- Degree Qualified in a Scientific discipline or similar.
- Registered QP and experience of working with biologics products and environments
- 3-5 years experience as a QP
- Experience working with and auditing CMO’s and CRO’s
- Experience of working with EMA.
- Dutch speaking is preferred but not essential.
If this is something that you would like to learn more about or think you would be a good fit, please apply now and one of our consultants will reach out to discuss the details further!