We are looking for a Scientist or Pharmacist who is looking for the next step to progress their career within Quality Assurance.
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 continue to develop your quality management and leadership expertise.
This is an exciting time to join us 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 England's pathfinder sites. Our team is expanding to support the build of a new Aseptic Hub to manufacture medicines for the WYAAT collaborative, with hospitals in the region working together for the best possible patient care.
As well as working as a releasing officer for different product types, you will also be involved in the management of the quality system, with a focus on the quality risk management. You will also have the opportunity to support the training of future clinical scientists.
If you are passionate about making a difference, this will be a great opportunity to be part of building the future of a highly valued service.
This is a 12-month fixed term contract, and secondments will be considered. Interviews are scheduled for 30 January 2025.
Main duties of the job
This 1-year fixed term role will focus on:
1. Acting as a Releasing Officer in the Aseptic Production Unit and/or the Dispensing Support Unit.
2. Performing a range of highly specialist activities including effective management of the Pharmaceutical Quality System e.g. quality risk management, root cause analysis, out of specification results and change management.
3. Using your specialist knowledge to perform, and support coordination of, research innovation and continuous improvement within the Pharmacy Preparative Service.
4. Providing specialist advice and guidance to the Pharmacy Preparative Service and the wider MMPS departments.
5. Coordinating, developing and delivering specialist training and supervision within Pharmacy Quality Control/Quality Assurance.
6. Mentorship/line management of trainees.
The post is full-time, working 37.5 hours per week Monday-Friday. There will also be some Bank Holiday and weekend commitments (13 days per year). The department aims to support flexible working arrangements, and we have car parking on site.
About us
The Pharmacy Department at LTHT is highly respected, forward-thinking and recognised within the organisation for collaborative working. We offer excellent career progression whilst working in a friendly and supportive team. We are also part of the West Yorkshire Association of Acute Trusts (WYAAT), a collaborative of the NHS hospital trusts from across West Yorkshire and Harrogate working together to provide the best possible care for our patients.
The QA/QC team has been instrumental in supporting the LTHT Pharmacy Manufacturing Unit in developing an industry-leading service, producing ready-to-administer injectable medicines. We are proud to say that we have created a positive working environment with a hardworking and dedicated workforce who feel valued and share a team goal to put the patients first.
Leeds Teaching Hospitals is committed to our process of redeploying 'at risk' members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions.
Job responsibilities
This post will work with the Pharmacy Quality Controller and QA Service Manager and QA Team Leader - Pharmacist in ensuring that all MHRA licensed medicine preparation and distribution within the facility at Moor House is carried out in accordance with relevant regulations and cGxP.
The post-holder will act as a Releasing Officer for the Pharmacy Manufacturing Unit (PMU) under the terms of the MHRA Specials Licence. This activity involves being responsible for the quality and safety of released batches of intravenous preparations manufactured in the Aseptic Production Unit (APU). 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 (DSU). Batches manufactured in this unit are supplied to LTHT and other users within the local Health economy.
The post-holder will work in partnership with the Pharmacy Quality Controller and QA Service Manager in ensuring that all unlicensed LTHT Aseptic and Radiopharmacy facilities are operating in accordance with current guidance and cGMP.
Provide input into the coordination, development and delivery of highly specialist education and training on aspects of Good Manufacturing Practice (cGMP) and other QA/QC practices and procedures within Pharmacy Preparative Services (including pharmacists, scientists, pharmacy technicians, and pharmacy support workers) and Trust wide where appropriate.
Co-ordinate and develop training programmes, where required, to complement areas of specialist knowledge, research and practice.
Manage staff providing specialised preparative and/or QC/QA services.
Utilise highly specialist knowledge, skills and experience to critically appraise deviations, analyse data and identify solutions to optimise technical processes and implement strategies for continuous improvement.
Under the leadership of the Pharmacy Quality Controller and QA Service Manager and the Preparative Services managers, ensure all records within the electronic Pharmaceutical Quality System are complete and accurate. Reviews and develops the system as required.
Performs and trains others to successfully perform quality investigations, risk assessment, root cause analysis, CAPA management and impact assessments.
Review, analyse and develop periodic Assurance Reports and associated data in relation to the Pharmaceutical Quality System as required, providing relevant guidance to service managers.
Undertake research to inform continuous improvement and innovation across the Preparative Service and beyond.
Provide highly specialist advice and guidance MMPS Preparative Service and the wider Medicines Management & Pharmacy Service.
Participate in evening, weekend and bank holiday rota and where appropriate, out of hours services.
Provide support for the Preparative Service Leadership team in the investigation and actions from errors and incidents and response to audits.
Ensure aseptic preparation is carried out efficiently and responsively and in compliance with current legislation and standards and the principles of Good Manufacturing Practice.
Contribute to the development and maintenance of a suitable training programme and delivery of this programme within MMPS Quality Control / Quality Assurance department.
Leads a team of technical and support staff in the Quality Assurance Service ensuring they have appropriate induction, regular appraisals, personal development plans and challenging but realistic objectives.
Conduct sickness and disciplinary reviews as required.
Ensure Trust Absence Management policy is adhered to and that staff absence is reported and return to work interviews conducted in a timely manner.
Responsible for recruitment and selection of technical and support staff.
Ensures regular team briefings and meetings are held and that there is good communication for all staff using a variety of means, written and verbal.
Provides operational support within Preparative Services, including sessional supervision, accuracy checking and product release. This will usually be on a planned basis.
Maintains high professional standards at all times and ensure compliance with statutory regulations concerning pharmaceuticals and the provision of Health and Safety at work are complied with.
Promotes the cost-effective use of equipment and supplies and to ensure that appropriate ordering and costing procedures are in place.
Works with key stakeholders in ensuring the delivery of training and competency assessments for staff working within the preparative service, including supporting the assessment of STP Trainees.
Identifies and implements risk reduction strategies in Preparative Service areas, in support of the Preparative Services Management Team.
Develops efficient communication channels with the rest of MMPS and key customers, ensuring good understanding of the service and the roles and responsibilities of staff.
Contributes to pharmacy service developments and ensure that change is managed smoothly in relation to area of responsibility.
Leads the implementation of new changes, based on best evidence or expert scientific opinion.
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 quality assessment of unlicensed medicines.
Undertakes critical review of stability studies and related product literature.
Assists in Health and Safety Management.
Participates in research and development activities within speciality including formulation and product development.
Plans and performs GMP and GDP internal quality audits in MHRA licensed facilities and all other Preparative Services areas and takes action to remedy deficiencies to continually improve the quality of the service.
Plans and performs Governance Audits in Preparative Services dispensing areas.
Provides scientific support and highly specialist advice to the MMPS Leadership team on a range of issues, including those outside the Preparative Service.
Supervises, teaches, and assesses junior pharmacy staff completing training modules within Preparative Services.
Person Specification
Qualifications
* Honours and Masters Degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences OR Masters degree in Pharmacy OR Post Grad Diploma in Pharmaceutical Technology or similar.
* Eligible for registration with the Health and Care Professions Council (HCPC), General Pharmaceutical Council (GPhC), Royal Society of Chemistry (RSC), Institute of Biology or equivalent body.
* Relevant training in Batch aseptic production and Good Manufacturing practice.
* Relevant training in Quality Management.
Skills and Behaviours
* Able to cope with conflict and handle difficult situations.
Experience
* Undertaking research, innovation and continuous improvement.
* Highly specialist knowledge and experience to act as a Releasing Officer for relevant product types.
* Root cause analysis.
* Change management.
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.
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