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Associate QA Clinical Manufacturing Breda
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SIRE Life Sciences
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Gevraagd
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Fulltime
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Medior
Aanbod
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Vast contract
Vacature in het kort
Join a leading Biotechnology company, making a real difference in patients' lives worldwide. In this role, you'll oversee quality in clinical packaging and the supply chain of trial products, ensuring they meet high standards. Your work will involve reviewing batches, checking compliance, and approving clinical labels. This position offers a unique chance to contribute to the health of millions, working within a team dedicated to excellence and innovation. Read on to find out why we could be the ideal fit for you.Volledige vacaturetekst
Associate QA Clinical Manufacturing
The Company
Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.
Role Description
As an Associate QA Clinical Manufacturing you will be responsible for providing quality oversight in the clinical packaging area and on the Supply Chain of Clinical Trial Products, ensuring compliance with GDP and GMP requirements.
Responsibilities
– Responsible for batch review, to support QP batch certification of Investigation Medicinal Product in compliance with EU regulations.
– Compliance review and approval of clinical label artwork.
– Review and approve deviations, ensuring all the process.
– Review SOP’s ensuring Corporate Site and Regulatory requirements.
Requirements
– Master Science degree, in Life Sciences preferable in Pharmacy.
– Typically, 3 years of related experience in QA or manufacturing experience in pharmaceutical or medical device industry.
– Experience in batch record review, investigation and analytical testing.
– GMP , GDP and or GCP knowledge.
Other information
Are you interested? Feel free to contact me!
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