PRINCIPAL DUTIES & AREAS OF RESPONSIBILITY General and Clinical Supports the Trust's Prescribing Standards and challenges practice where prescribers have not adhered to the Medicines Code. Manages difficult problems including providing advice on production, COSHH issues and issues relating to safe use of unlicensed medicines. In some situations information may be ambiguous or limited and opinions may differ on preferred outcomes Undertakes risk management, including investigating clinical incidents, and ensuring compliance with medicines legislation. Undertakes risk management including investigating errors and non-conformances in Preparative Services and COSHH incidents in any Trust area. The post holder will be expected to identify, where necessary, areas that require service changes and develop a strategy to carry out the change in accordance with the change control procedure. The service changes identified may be internal to Preparative Services or impact the service as a whole. Manages the introduction of new drugs, including quality assessment of unlicensed drugs. Preparative Services: Professional Release of Licensed Batch Manufacture - This activity involves being responsible for the quality and safety of released batches of intravenous preparations manufactured in the Aseptic Production Unit under the terms of the MHRA (Medicines & Healthcare Regulatory Agency) Specials Licence. It also involves being responsible for the quality and safety of individual released batches of oral and topical preparations manufactured in the Dispensary Support Unit under the terms of the MHRA Specials Licence. Products prepared in this unit are supplied to LTHT and other users within the local Health economy including Local Care Direct and local health Trusts. Supports the QA/QC manager in ensuring that all licensed medicine preparation within the Trust is carried out accordance with cGMP. Professional Supervision of Aseptic Dispensing. Working on a rota as part of a team of pharmacists, the job holder will be responsible for supervising aseptic dispensing sessions and releasing products. May be expected to gain experience in Radiopharmacy and provide professional support to this area as required. Performs pharmaceutical quality assessment of unlicensed medicines including approval of Quality Assessment reports on individual medicines. To include quality risk assessment where information on either the drug or the clinical usage is limited or conflicting. Delivers training sessions on COSHH and Risk Assessment to multidisciplinary groups. Develops and maintains Quality Systems and Information Resources Assists the QC/QA Manager in Health and Safety/Risk Management Participates in research and development activities within speciality including formulation and product development. Plans and performs GMP and GDP audits in MHRA licensed facilities and all other Preparative Services areas. Plans and performs Governance Audits in Preparative Services dispensing areas. Supervises, teaches, and assesses junior pharmacy staff completing training modules within QA/QC and develop suitable training programmes