Clinical Supply Chain QA Specialist

Clinical Supply Chain QA Specialist (interim opdracht) voor een opdrachtgever in Breda, regio Brabant, Limburg, Zeeland. Het profiel van de geschikte interim professional: Master's degree, ideally in Life Sciences or a comparable discipline; multi-year background in Quality Assurance and/or manufacturing within the pharmaceutical, biotech or medical device sector; hands-on experience with documentation review, such as batch records, and deviation/investigation support; solid knowledge of GMP and GDP (GCP knowledge is a plus); keen eye for detail, methodical approach and a compliance-driven mindset; effective communication skills combined with the ability to work with various stakeholders; fluent in English.

Taken & verantwoordelijkheden: Provide quality assurance oversight for clinical supply operations in line with GMP/GDP requirements. Provide QA guidance and oversight for investigational medicinal products to ensure GMP/GDP compliance; check batch records to facilitate batch certification; assess and sign off clinical label designs, and assist with quality checks on packaging and labelling; evaluate and record temperature deviations occurring during transport or at clinical sites and depots; support investigation and resolution of quality and compliance issues in manufacturing, packaging and distribution; review and approve minor deviations according to internal procedures and regulatory expectations; create, revise and keep operational SOPs and work instructions up to date; review SOPs for alignment with corporate standards, site procedures and regulations; compile and contribute input for monthly quality reports and metrics; work closely with teams across supply chain, warehouse/distribution, production, quality, clinical operations and regulatory affairs; perform QA-on-the-floor activities such as pack checks and batch record reviews during manufacturing.