Are you a talented Scientist or Pharmacy Technician with experience in GMP, Quality Assurance (QA) or Quality Control (QC)? Are you looking to improve patient care by supporting the production of specialist medicines and infusions?
Do you enjoy working in a dynamic, collaborative, and supportive environment with a varied portfolio of work?
This is an excellent opportunity to showcase your skills, whist benefiting from access to great training and development opportunities.
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 at Leeds Teaching Hospitals (LTHT) is therefore expanding to support the build of a new Pharmacy Aseptic Hub. 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 and quality control activities to support our Pharmacy Manufacturing Unit to produce specialist medicines and infusions.
If you are passionate about making a difference this will be a great opportunity to be part of the building the future of a highly valued service.Main duties of the job
Duties will include but are not limited to:
Plan and manage projects to support continuous improvement within LTHT Preparative Services.
Act as a Releasing Officer / QC Checker in the dispensary support unit +/- aseptic production unit.
Oversight, supervision and troubleshooting for QC laboratory activity (Chemistry +/- Microbiology) and physical environmental monitoring and temperature monitoring activities.
Performing activities in relation to the Pharmaceutical Quality System e.g. quality risk management, root cause analysis, investigating out of specification results and change management.
Act as a Quality Controller for Medical Gas Pipeline Systems
Provide QA related support to the LTHT (Section 10) Preparative Services departments.
To manage the policies, procedures and equipment used within the QA/QC service and ensure regulatory compliance with GLP & GMP.
Provide support and training to other staff members within the LTHT team.
Support validation activities within MMPS.About us
LTHT is one of the largest and busiest acute hospital trusts in the UK. The Leeds Way provides a strong foundation for the way we all work together, acting with compassion, empathy, and kindness towards our patients and each other.
The Pharmacy Department at LTHT is highly respected, forward thinking and recognised within the organisation for collaborative working. Our vision is, making it easy for people to get the most from their medicines and we are continually innovating to improve our services for patients and staff.
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. The QA/QC team benefits from a supportive and innovative environment.
The department aims to support flexible working arrangements and we have car parking on site.
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 descriptionJob responsibilities
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.Person SpecificationExperienceEssential
- Good dispensing, distribution & manufacturing practice
- Accuracy checking training
- Knowledge of clean room design and functioning
- Risk assessments
- Able to cope with a large and varied workload
- Able to work accurately and under pressure
- Good IT skills (Excel, Word and Powerpoint)
- Honours degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or similar) OR BTEC in pharmaceutical science or NVQ level 3 in pharmacy services
- 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
Skills and BehavioursEssential
- Further education in Pharmacy Technical Services e.g. PTQA or STP
Employer detailsEmployer name
- Enthusiastic & reliable
Leeds Teaching HospitalsAddress
St. James's University Hospital
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