Weare looking for a registered Pharmacist who is looking for the next step toprogress their career in pharmaceutical quality assurance with thisleadership role.
Aswell as the standard NHS benefits, this is a great opportunity to workalongside like-minded professionals in a dynamic, collaborative, andsupportive environment with a varied portfolio of work to support patientcare at LTHT. This post is an excellent opportunity to both showcase, anddevelop, your leadership skills and expertise. This is a great time to joinour department as we are part of a national programme to transform asepticservices in England, with West Yorkshire Association of Acute Trusts (WYAAT)identified as one of five pathfinder sites.
TheQA/QC team is growing prior to our movement to our new build premises in2026. The new facility willmanufacture medicines on behalf of the WYAAT collaborative, which seeshospitals working together to provide the best possible care for patients inWest Yorkshire and Harrogate. Thepost holder will join our existing QA/QC team, part of Pharmacy PreparativeServices within LTHT - one of the busiest in the UK. Their role will beprimarily to perform quality assurance activities to support our MS LicensedPharmacy Manufacturing Unit and our Section 10 Aseptic Service to producespecialist medicines and infusions.
Main duties of the job
Dutieswill include but are not limited to:
Supportthe Service Manager to provide oversight & leadership to the QA/QCTeam.
Ensurethe effective management of the Pharmaceutical Quality System e.g. qualityrisk management, root cause analysis, out of specification results and changemanagement.
Providesubject matter expertise in relation to GMP, Pharmaceutical Quality Assuranceactivities and Quality Risk Management.
Planand manage projects to support continuous improvement within LTHT PreparativeServices.
Ensurethat all activity performed within the scope of the MHRA MS Licence &WDA(H) Authorisation comply with the relevant regulations and guidance.
Ensurethat staff are highly trained and assessed against current procedures andcompetencies. This involves working closely with the department Team Leadersand other Education and Training Teams.
Actas a Releasing Officer in the dispensary support unit and aseptic productionunit.
ProvideQA leadership and support to the LTHT (Section 10) Preparative Servicesdepartments.
Providesupport and training to other staff members within the LTHT team.
Linemanagement of substantive staff +/- trainees.
Thepost is full-time, working 37.5 hours per week Monday-Friday. Flexibleworking options can be discussed.There will also be some Bank Holiday and weekend commitments (13 daysper year).
Interviewswill be held on 16 January 2025.
About us
LeedsTeaching Hospitals is one of the largest and busiest NHS Trusts in thecountry, offering a range of both general and specialist hospital serviceswith excellent clinical outcomes for patients. We have an internationalreputation for excellence in specialist care, research and academic training.
Weare also part of the West Yorkshire Association of Acute Trusts (WYAAT), acollaborative of the NHS hospital trusts from across West Yorkshire andHarrogate working together to provide the best possible care for ourpatients.
ThePharmacy Department at LTHT is highly respected, forward thinking andrecognised within the organisation for collaborative working. We offerexcellent career progression whilst working in a friendly and supportiveteam.
TheQA/QC team has been instrumental in supporting the LTHT PharmacyManufacturing Unit in developing an industry leading service, producing readyto administer injectable medicines.
LeedsTeaching Hospitals is committed to our process of redeploying 'at risk'members of our existing workforce to new roles. As such, all our job advertsare subject to this policy and we reserve the right to close, delay or removeadverts while this process is completed. If you do experience a delay in theshortlisting stage of the recruitment cycle, please bear with us while thisprocess is completed, and contact the named contact if you have anyquestions.
Job responsibilities
PRINCIPALDUTIES & AREAS OF RESPONSIBILITY
Generaland Clinical
Supports the Trust's PrescribingStandards and challenges practice where prescribers have not adhered to theMedicines Code.
Manages difficult problemsincluding providing advice on production, COSHH issues and issues relating tosafe use of unlicensed medicines. In some situations information may beambiguous or limited and opinions may differ on preferred outcomes
Undertakes risk management,including investigating clinical incidents, and ensuring compliance withmedicines legislation.
Undertakes risk managementincluding investigating errors and non-conformances in Preparative Servicesand COSHH incidents in any Trust area.
The post holder will be expected toidentify, where necessary, areas that require service changes and develop astrategy to carry out the change in accordance with the change controlprocedure. The service changes identified may be internal to PreparativeServices or impact the service as a whole.
Manages the introduction of newdrugs, including quality assessment of unlicensed drugs.
PreparativeServices:
Professional Release of LicensedBatch Manufacture - This activity involves being responsible for the qualityand safety of released batches of intravenous preparations manufactured inthe Aseptic Production Unit under the terms of the MHRA (Medicines &Healthcare Regulatory Agency) Specials Licence.
It also involves being responsiblefor the quality and safety of individualreleased batches of oral and topical preparations manufactured in the Dispensary Support Unitunder the terms of the MHRA Specials Licence. Products prepared in this unitare supplied to LTHT and other users within the local Health economyincluding Local Care Direct and local health Trusts.
Supports the QA/QC manager inensuring that all licensed medicine preparation within the Trust is carriedout accordance with cGMP.
Professional Supervision of AsepticDispensing. Working on a rota as part of a team of pharmacists, the jobholder will be responsible for supervising aseptic dispensing sessions andreleasing products.
May be expected to gain experiencein Radiopharmacy and provide professional support to this area as required.
Performs pharmaceutical qualityassessment of unlicensed medicines including approval of Quality Assessmentreports on individual medicines. To include quality risk assessment whereinformation on either the drug or the clinical usage is limited or conflicting.
Delivers training sessions on COSHHand Risk Assessment to multidisciplinary groups.
Develops and maintains QualitySystems and Information Resources
Assists the QC/QA Manager in Healthand Safety/Risk Management
Participates in research anddevelopment activities within speciality including formulation and productdevelopment.
Plans and performs GMP and GDPaudits in MHRA licensed facilities and all other Preparative Services areas.
Plans and performs GovernanceAudits in Preparative Services dispensing areas.
Supervises, teaches, and assessesjunior pharmacy staff completing training modules within QA/QC and developsuitable training programmes
Person Specification
Experience
* Highly advanced knowledge and understanding of the principles of cGMP and cGDP
* An understanding of team dynamics and effective leadership strategies to optimise performance
Skills & behaviours
* Be highly adaptive to changing circumstances and situations
* Highly developed influencing and negotiating skills
Qualifications
* Registrant of the GPhC
* Post qualification experience (min requirement to act as releasing officer in MHRA licenced unit)
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
#J-18808-Ljbffr