Quality Assurance Manager – Technical Services | Nottingham University Hospitals NHS Trust
| Posting date: | 14 May 2025 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | £53,755 - £60,504 per annum |
| Hours: | Full time |
| Closing date: | 13 June 2025 |
| Location: | Nottingham, NG7 2UH |
| Company: | Nottingham University Hospitals NHS Trusts |
| Job type: | Permanent |
| Job reference: | 7210105/164-7095131-A |
Summary
The Pharmacy Quality Assurance (QA) team is responsible for driving quality within the whole of Pharmacy Technical Services, which includes the Sterile Production, Non-Sterile Production, and Prepacking Units, Pharmacy Stores, Quality Control and Quality Assurance functions based at QMC and Cytotoxic Chemotherapy Laboratory on the City Hospital Campus.
The post holder will support the Head of Quality with all aspects of QA to ensure that the service is fit for purpose. This will be achieved by taking a lead role in developing and implementing an effective(QMS); and managing the QA team.
The post holder will provide Quality Assurance leadership and support to all licensed and unlicensed production facilities, QC laboratory, and areas covered by the Wholesale Dealing Authorisation, in accordance with the strategic framework as defined by the Head of Quality. They will also develop and implement the QMS within the Radiopharmacy Department to enable integration of all sections of Technical Services.
The post holder will lead the QMS development, by providing leadership, support, expert advice and guidance. The post holder will be expected to deliver on a range of projects, and lead on the development of wider Quality Assurance issues.
The post holder will be expected to liaise with regulatory bodies such as the MHRA and Regional Quality Assurance Specialists, as well as NUH and non-NHU clients and senior members of the Pharmacy team and Clinical Support Division.
The post holder will provide Quality Assurance leadership and support to all licensed and unlicensed production facilities, QC laboratory, and areas covered by the Wholesale Dealing Authorisation, in accordance with the strategic framework as defined by the Head of Quality. They will also develop and implement the QMS within the Radiopharmacy Department to enable integration of all sections of Technical Services.
The post holder will lead the QMS development, by providing leadership, support, expert advice and guidance. The post holder will be expected to deliver on a range of projects, and lead on the development of wider Quality Assurance issues.
This will be done through development, planning, co-ordinating, delivering and evaluation of operational activity within Technical Services, ensuring excellent communication channels are built and ensuring work is completed within deadlines.
The post holder will be expected to liaise with regulatory bodies such as the MHRA and Regional Quality Assurance Specialists, as well as NUH and non-NHU clients and senior members of the Pharmacy team and Clinical Support Division.
With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.
Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour to turn your job into a career!
We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.
1. To support the Head of Quality in developing and maintaining the QA services to a standard that can safely meet the Trust and patients’ needs and maintain the relevant MHRA licences held
2. To develop, implement and manage the Quality Management System for Pharmacy Technical Services, to include but not limited to deviation management, change control, complaints and corrective and preventative actions.
3. To develop and monitor quality indicators to critically assess the Quality Management System ensuring the principles of continuous quality improvement are maintained.
4. To compile and collate information and lead the designated team responsible for investigations of quality exception reports.
5. To track and establish trends in quality exception reports and ensure identified trends are escalated
6. To develop and manage the Documentation Management System, ensuring that all required documentation is available and accurately reflects the actual practices undertaken. This will require the post holder, authors, reviewers and approvers to work together in a positive and collaborative manner to ensure documents are reviewed and approved in a timely manner.
7. To respond to customer complaints and undertake drug defect investigations for NUH manufactured products
8. To support senior Production and Quality Control staff in monitoring available capacity to ensure adequate staffing resource is available.
9. Work closely with cross functional teams responsible for manufacturing, quality assurance, suppliers/service providers, Finance and clinical services to ensure correct reporting of data and resolve any queries utilising validated PQS systems and processes and provide expert guidance on manufacturing/quality related issues
10. To develop and maintain the Validation Master Plan in conjunction with senior production and Quality Control staff. This should include validation of facilities, equipment, processes and computer systems.
11. To monitor compliance and timely completion of validation activities to ensure the key objectives of the Validation Master Plan are met.
12. To maintain Quality Assurance records, both paper and electronic, in compliance with current guidance, data integrity and legal responsibilities.
13. To develop and maintain the internal audit programme
14. To monitor compliance and timely completion of audit activities.
15. To carry out regular internal audits as part of the team of designated auditors to ensure compliance with GMP and GDP.
16. To participate in external inspections carried out by MHRA or SPS QA Specialists to ensure ongoing regulatory compliance.
17. Provide a source of expertise and guidance on procedures for all Quality related disciplines in line with MHRA Guidelines, EUDRALEX Vol 4, PIC/S, Quality Assurance of Aseptic Preparation Services (QAAPS) and NHS Yellow cover documents.
18. Keeping abreast of MHRA regulatory/ICH standards, requirements and GxP procedures/policies and undertaking the implementation of these policies. Interpret and lead on the local implementation of these policies across the Technical Services department and managing cultural change as required to embed new ways of working.
19. To collate audit findings (internal and external) and lead on the development and implementation of action plans in response to identified deficiencies.
20. To develop and support the implementation of appropriate Quality Assurance training programmes for pharmacy staff
21. To maintain and develop links with relevant professional bodies and organisation e.g. General Pharmaceutical Council, Medicines and Healthcare products Regulatory Agency, Specialist Pharmacy Services.
22. To act as a Releasing Officer where necessary for manufactured, repackaged and overlabelled products under the MHRA (Specials) Licence
This advert closes on Wednesday 28 May 2025