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(Sr.) Qualified Person

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13 SEP '23: Join a leading biopharmaceutical company based in Leiden, and make a difference in the field of immunotherapies. As a (Sr.) Qualified Person, you will play a pivotal role in the release of finalised pharmaceutical batches, contributing to the development of innovative allergy treatments. This is an exciting opportunity to join a dynamic team and drive the success of groundbreaking research projects.




Leiden - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

As the (Sr.) Qualified Person you will focus on the batch certification and release of pharmaceutical products in accordance with the Marketing Authorisation/IMPD and in accordance with current EU-Directives. Part of the role entails to investigate in close collaboration with the Deviations Specialist and approve/finalise the deviation(s), approval of Change Controls and being the focal point of contact with regulatory authorities (IGZ, Farmatec, PEI) to maintain the compliance status. Moreover, you will participate in R&D Project teams as QA-representative, focus on approval and execution, including follow-up of internal – and external (supplier) audits and support quality-based decision processes. You will also participate in developing and training QA-Officers and actively support a climate for continuous improvement, take care of maintenance of the Quality Management Systems: Auditing, Deviations and Product Quality Review.

QTC logo icon what's needed

What you bring

To qualify for this position you have at minimum a M.Sc. Degree (preferred as Pharmacist), and you are eligible as Qualified Person as per IGZ regulations. Moreover you bring along;
  • Experience (QP: 2yrs +) with aseptical manufacturing;
  • Solid knowledge of (bio-)pharmaceutical processes and – industry (R&D, QC and production);
  • Experience with the implementation and maintenance of Quality Management Systems;
  • Audit experience and interview techniques;
  • Fluency in both the Dutch and English language.

QTC logo icon What we offer

What's in it for you

As (Sr.) Qualified Person you will be part of a steadily growing and dynamic organisation on Leiden's Bioscience Parc offering a great environment for self-starters.
  • A competitive base salary, tailored to experience;
  • A 13th month salary;
  • 30 holidays;
  • Company contribution to a pension package;
  • Heath insurance;
  • Personal development budget (for training purposes).

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