Lead Pharmacy Technician – Aseptic Clinical Trials and Production

Lead responsibility for the management of the preparation of aseptically prepared Investigational Medicinal Products Responsible for the effective introduction and management of aseptically prepared clinical trial products, ensuring that the preparation of aseptic product for clinical trial is limited to reconstitution activities. Manage clinical trial material in the Aseptic Unit (including ordering, receipt, storage and documentation). Responsible for the maintenance of all procedures that relate to the reconstitution of Investigational Medicinal Products and comparators. Establishment of GMP instructional documents that will act as source information for staff in the Aseptic Unit for each Clinical Trial Project. Establishment of product specific documents (source information and production work sheets) for use in the Aseptic Unit for each Clinical Trial Project. Conduct final check of aseptic products on behalf of the Head of Production (prior to QA release to wards and customers). Support investigations related to events in production, particularly those that have involved clinical trial material. Responsible for the direct line management of pharmacy technicians and assistants. Responsible for the co-ordination and prioritisation of the Aseptic Unit workload. The job role will be split as approximately 0.6WTE undertaking clinical trial responsibilities and 0.4WTE undertaking production responsibilities. Perform duties in accordance with departmental procedures, GMP and hospital policy.