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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 uur per week

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Zo maak jij het verschil

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.

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Wat jij mee brengt

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.

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Jouw voordelen

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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