About the RoleWe are looking for an experienced Quality Assurance Specialist to support Clinical Supply and Cold Chain activities. The ideal candidate will help review and approve GDP documentation generated in the context of the supply of products for clinical studies, ensuring full compliance across manufacturing sites, CMOs, CROs and clinical sites.

• Key ResponsibilitiesReview of supply flow in line with clinical logistics strategy and qualified status of providers used
• Review of feasibility analysis of transfers between commercial sites, technical R&D GMP department, and its CMOs, or between clinical sites, to ensure quality attributes of products received and compliance of providers used
• Generation and/or review of cold chain documentation provided to CMOs/CROs to confirm storage conditions and cold chain budget allocated to CMO/CRO activities
• Determination of the cold chain budget available at the time of release of batches prior to shipment to clinical sites
• Assessment of temperature excursions during storage or distribution of products for clinical studies

• Main ActivitiesReview supply and transfer flows against clinical logistics strategy and provider qualification status
• Assess feasibility of transfers between production sites, R&D GMP, CMOs and clinical sites
• Draft and/or review cold chain documentation for CMO/CRO storage and distribution activities
• Calculate and track available cold chain budget ahead of batch release
• Investigate and document temperature excursions, proposing impact assessments where required
• Liaise with GMP and Clinical Operations teams to support root-cause analysis and continuous improvement

• Required QualificationsMaster's degree in Sciences/Engineering (e.g. Pharmacist, Bioengineer, Master in Sciences) — mandatory
• 3 to 5 years of experience in a Quality Assurance environment, ideally in the pharma industry
• Knowledge of cGMP, GDP, cold chain, manufacturing operations, clinical trial and regulatory requirements
• Strong scientific background to understand study objectives and interact with both GMP and Clinical Operations
• Understanding of how clinical trials are set up and run, including the associated legal and regulatory framework
• Excellent communication skills, both written and verbal, with the ability to drive root-cause discussions
• Fluent in English
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