Leeds Teaching Hospitals r54Paij9
This full-time position (37.5 hours per week) includes some weekend and bank holiday commitments. The role emphasises leadership development within a collaborative environment, as the department participates in a national initiative to enhance aseptic services. The successful applicant will work closely with a variety of health professionals, bringing subject matter expertise in Good Manufacturing Practice (GMP) and Quality Risk Management to the forefront of their responsibilities. Interviews for this position are scheduled for January 16, 2025.
Interview Date- 16 January 2025
We are looking for a registered Pharmacist who is looking for the next step to progress their career in pharmaceutical quality assurance with this leadership role.
As well as the standard NHS benefits, this is a great opportunity to work alongside like-minded professionals in a dynamic, collaborative, and supportive environment with a varied portfolio of work to support patient care at LTHT. This post is an excellent opportunity to both showcase, and develop, your leadership skills and expertise. This is a great time to join our department as we are part of a national programme to transform aseptic services in England, with West Yorkshire Association of Acute Trusts (WYAAT) identified as one of five pathfinder sites.
The QA/QC team is growing prior to our movement to our new build premises in 2026. The new facility will manufacture medicines on behalf of the WYAAT collaborative, which sees hospitals working together to provide the best possible care for patients in West Yorkshire and Harrogate. The post holder will join our existing QA/QC team, part of Pharmacy Preparative Services within LTHT - one of the busiest in the UK. Their role will be primarily to perform quality assurance activities to support our MS Licensed Pharmacy Manufacturing Unit and our Section 10 Aseptic Service to produce specialist medicines and infusions.
Duties will include but are not limited to:
Support the Service Manager to provide oversight & leadership to the QA/QC Team.
Ensure the effective management of the Pharmaceutical Quality System e.g. quality risk management, root cause analysis, out of specification results and change management.
Provide subject matter expertise in relation to GMP, Pharmaceutical Quality Assurance activities and Quality Risk Management.
Plan and manage projects to support continuous improvement within LTHT Preparative Services.
Ensure that all activity performed within the scope of the MHRA MS Licence & WDA(H) Authorisation comply with the relevant regulations and guidance.
Ensure that staff are highly trained and assessed against current procedures and competencies. This involves working closely with the department Team Leaders and other Education and Training Teams.
Act as a Releasing Officer in the dispensary support unit and aseptic production unit.
Provide QA leadership and support to the LTHT (Section 10) Preparative Services departments.
Provide support and training to other staff members within the LTHT team.
Line management of substantive staff +/- trainees.
The post is full-time, working 37.5 hours per week Monday-Friday. Flexible working options can be discussed. There will also be some Bank Holiday and weekend commitments (13 days per year).
Interviews will be held on 16 January 2025.
About us
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
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