QA/QC Specialist (XR06) Leeds, England
Job description
This post will work with the QA/QC Manager and QA Pharmacist in ensuring that all MHRA licensed medicine preparation and distribution within the LTHT MS Licensed facility is carried out in accordance with relevant regulations and cGxP. The post-holder also acts as a Releasing Officer for the Aseptic Preparation Unit +/- Dispensary Support Unit under the terms of the MHRA Specials Licence. The post-holder will work in partnership with the QA/QC Manager in ensuring that all unlicensed LTHT Aseptic and Radiopharmacy facilities are operating in accordance with current guidance and cGMP. In addition to supporting compounding activities at LTHT, this post will facilitate the delivery of high quality patient care by ensuring safety and quality of all products supplied to LTHT and external NHS customers.
This includes supporting the specification, development and procurement of new products and provision of highly specialist advice e.g. the quality assessment of unlicensed medicines. 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 QC/QA Manager 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 a minimum of at least three 4 hour sessions of service cover in the Pharmacy Manufacturing Unit, aseptic dispensary and/or radiopharmacy each week.
