QA Batch Release Specialist

The Company: A leading global biotechnology organization focused on developing and delivering innovative medicines for patients with serious illnesses. Its Breda operation brings together more than 1000 employees representing 38 nationalities across manufacturing, supply chain, commercial activities, and clinical research.

About the Role: The QA Batch Release Specialist provides Quality Assurance oversight for Investigational Medicinal Products throughout clinical supply chain activities. The position supports batch review for QP certification, clinical labeling, temperature excursion assessments, deviations, SOPs, and quality activities within clinical packaging and labeling operations. The role works closely with Clinical Supply Chain, Warehouse and Distribution, Production, Site Quality, Clinical Research Management, and Regulatory Affairs.

Responsibilities: Perform batch review to support QP batch certification of Investigational Medicinal Products according to EU and international requirements; review and approve clinical label artwork from a compliance perspective; assess temperature excursions occurring during transportation and at clinical sites; support resolution of compliance and quality issues associated with clinical product manufacturing and transportation; review and approve minor deviations and ensure procedural requirements are met; create and maintain operational SOPs and Work Instructions; review SOPs against corporate, site, and regulatory requirements; prepare monthly quality metrics; identify quality issues and collaborate cross functionally on solutions; provide Quality Assurance support within clinical packaging and labeling operations; perform packaging checks and batch record reviews; support issue handling during manufacturing activities; execute QA compliance checks on the production floor.

Requirements: Master of Science degree, preferably in Life Sciences or a related discipline; typically at least 3 years of relevant Quality Assurance or pharmaceutical or medical device manufacturing experience; experience with batch record review; experience with investigations and analytical testing; knowledge of Good Manufacturing Practice; knowledge of Good Distribution Practice and/or Good Clinical Practice; strong understanding of compliance and quality requirements; strong communication skills; fluent English.

Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.