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Spécialiste qualité
Randstad Professional BelgiumBraine-l’Alleud, Walloon Region, BelgiumIl y a 1 jour
Description de posteMinimum of 8 years working in the pharmaceutical / biologics industry in a quality management position QA GMP Mindset May demonstrate competence in complaint management, Regulatory affairs, and Analytical on biological products Autonomous Experience in problem solving Capability to treat information’s to propose solution in line with the client's expectations Able to present, defend topics to top management High motivation to deliver quality outputs within the given deadlines Understanding of CMC Regulatory requirement Fluent in English & good knowledge of French
The main activities as CMC Quality Solutions Specialist will be focused on :
- Working on Biological products
- Participate to meeting in place of the CMC Quality Lead
- Work on Submission file review
- Preparing complains committee with metrics establishment and with the ability to propose next steps to go ahead
- Answering to questions of client's or other partners to provide answers related to the product
- Challenging stability plan
- Creating / reviewing / approve Annual Product Quality Review
- Managing time of cold chain situations
- Participate to the PSUR (Periodic Safety Update Reports) creation and review
The requirements for this position of CMC Quality Solutions Specialist are :
We offer an attractive salary with benefits (car, insurance, monthly allowance, 7 euros meal voucher per day, ...). A rate as freelancer is also possible.
This is a contract as a Consultant until end of 2025 with possibility of extension.
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Spécialiste qualité • Braine-l’Alleud, Walloon Region, Belgium