JOB PURPOSE To ensure that the MMPS preparative service produces high quality products in line with all relevant standards and procedures, minimising risk to patients and healthcare professionals. To focus on continuous improvement across the preparative service with a specific focus on Aseptic Services and beyond. To maximise the effectiveness and influence of the Pharmaceutical Quality System in all preparation areas within MMPS. This is to ensure that high risk parenteral medicines are compounded and delivered in accordance with current Good Manufacturing Practice (cGMP).
This role will include a specific focus on validation and re-validation of key processes, people and equipment across the preparative service. To help manage a team of technical and support staff within preparative services and to perform a key supervisory and leadership role of at weekends and Bank Holidays. JOB DIMENSIONS This post will work closely with all areas across the MMPS Preparative Service, one of the biggest of its type in the UK. The service consists of: A Pharmacy Manufacturing Unit at Moor House, consisting of a Dispensary Support Unit (DSU) and Aseptic Production Unit (operating under a Specials licence from the MHRA) Two large unlicensed Aseptic Dispensaries at St James Hospital and Leeds General Infirmary (where this post will be based) An unlicensed Radiopharmacy Unit at St James Hospital A Quality Control/Quality Assurance Department at Moor House The post holder will work with the Accountable Pharmacist for Aseptic Services to ensure that all unlicensed medicine preparation and distribution within the aseptic units is carried out in accordance with standards specified in QAAPS and cGMP.
Contribute to training pharmacists, technicians, and pharmacy support workers on aspects of Good Manufacturing Practice (cGMP) and other QA/QC procedures within Preparative Services, MMPS and Trustwide where appropriate. Manage other staff providing specialised preparative and/or QC/QA services. Under the leadership of the Accountable Pharmacist and the service managers, ensure all records within the electronic Pharmaceutical Quality System are complete and accurate. Reviews and develops the system as required.
Produces periodic assurance reports in relation to the Pharmaceutical Quality System as required. Provide support for the Preparative Service Leadership team in the investigation and actions from errors and incidents and response to audits.