The Pharmacy Quality Assurance (QA) team is responsible for driving quality within the entire Pharmacy Technical Services, including Sterile Production, Non-Sterile Production, Prepacking Units, Pharmacy Stores, and Quality Control and Assurance functions at QMC and Cytotoxic Chemotherapy Laboratory on the City Hospital Campus.
The post holder will support the Head of Quality in all aspects of QA to ensure the service is fit for purpose. This includes leading the development and implementation of an effective Quality Management System (QMS) and managing the QA team.
Responsibilities include providing QA leadership and support to all licensed and unlicensed production facilities, QC laboratories, and areas covered by the Wholesale Dealing Authorization, aligning with the strategic framework set by the Head of Quality. The post holder will also develop and implement the QMS within the Radiopharmacy Department to facilitate integration across Technical Services.
The role involves leading QMS development through leadership, support, expert advice, and guidance. The post holder will deliver on various projects and address broader Quality Assurance issues.
This will be achieved through planning, coordinating, delivering, and evaluating operational activities within Technical Services, ensuring effective communication and timely completion of work.
The post holder will 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 and Clinical Support Division.
NUH employs over 19,000 staff and is a major employer committed to research, education, and innovation. We value diversity and welcome new ideas to develop our team and deliver world-class healthcare. We offer extensive personal development opportunities to turn your job into a career.
We particularly encourage applications from individuals who identify as Black, Asian, and Minority Ethnic, or Disabled, as part of our commitment to better representation.
Minimum Responsibilities:
1. Support the Head of Quality in developing and maintaining QA services to meet Trust and patient needs, ensuring compliance with MHRA licenses.
2. Develop, implement, and manage the QMS for Pharmacy Technical Services, including deviation management, change control, complaints, and CAPA.
3. Develop and monitor quality indicators to ensure continuous quality improvement.
4. Lead investigations of quality exception reports and analyze trends for escalation.
5. Manage the Documentation Management System, ensuring accuracy and timely review and approval of documents.
6. Respond to customer complaints and conduct drug defect investigations for NUH-manufactured products.
7. Support senior staff in monitoring capacity and staffing resources.
8. Collaborate with cross-functional teams to ensure proper data reporting, resolve issues, and provide expert guidance on manufacturing and quality matters.
9. Develop and maintain the Validation Master Plan, including validation of facilities, equipment, processes, and systems.
10. Ensure compliance with validation activities and maintain QA records in line with guidance and legal requirements.
11. Develop and oversee the internal audit program, ensuring timely completion and compliance with GMP and GDP.
12. Participate in external inspections by MHRA or SPS QA Specialists to ensure ongoing regulatory compliance.
13. Provide expertise on procedures aligned with MHRA, EUDRALEX, PIC/S, QAAPS, and NHS standards.
14. Stay updated on MHRA, ICH, and GxP standards and lead their implementation within the department.
15. Address audit findings and develop corrective action plans.
16. Support QA training programs for pharmacy staff and maintain links with professional bodies.
17. Act as a Releasing Officer for products under the MHRA (Specials) Licence, if required.
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