Quality Assurance Manager Technical Services Nottingham University Hospitals NHS Trust

Job Description: Quality Assurance Pharmacist

The Pharmacy Quality Assurance (QA) team is responsible for driving quality within Pharmacy Technical Services, including Sterile Production, Non-Sterile Production, Prepacking Units, Pharmacy Stores, Quality Control, and Quality Assurance functions at QMC and Cytotoxic Chemotherapy Laboratory.

The post holder will support the Head of Quality in all QA aspects to ensure service suitability. This involves leading the development and implementation of an effective Quality Management System (QMS) and managing the QA team.

Key responsibilities include providing QA leadership to licensed and unlicensed production facilities, QC laboratories, and areas under Wholesale Dealing Authorization, aligning with the strategic framework set by the Head of Quality. The role also involves developing and integrating the QMS within the Radiopharmacy Department.

The post holder will lead QMS development through leadership, support, expert advice, and guidance, delivering various projects and addressing broader QA issues. They will liaise with regulatory bodies like MHRA, Regional QA Specialists, NUH, non-NHU clients, and senior pharmacy and clinical staff.

This role requires overseeing operational activities within Technical Services, ensuring effective communication and timely completion of tasks. The post holder will support the development, planning, coordination, delivery, and evaluation of QA activities.

NUH is a major employer supporting health, research, education, and innovation, committed to diversity and personal development. We welcome applications from Black, Asian, Minority Ethnic groups, and disabled individuals.

Minimum Responsibilities:

1. Support the development and maintenance of QA services to meet Trust and patient needs, ensuring MHRA licenses are upheld.
2. Develop, implement, and manage the QMS for Pharmacy Technical Services.
3. Monitor quality indicators to ensure continuous quality improvement.
4. Lead investigations of quality exception reports and track trends for escalation.
5. Manage the Documentation Management System, ensuring accuracy and timeliness.
6. Respond to customer complaints and investigate drug defects for NUH products.
7. Support staffing and capacity monitoring in collaboration with senior staff.
8. Work with cross-functional teams to ensure accurate data reporting and resolve manufacturing/QA issues.
9. Develop and maintain the Validation Master Plan, overseeing validation activities.
10. Maintain QA records in compliance with guidance and legal requirements.
11. Develop and monitor the internal audit program, participating in external inspections.
12. Provide expertise on procedures aligned with MHRA, EUDRALEX, PIC/S, and NHS standards.
13. Stay updated with regulatory standards and lead policy implementation.
14. Lead audits, develop action plans for deficiencies, and support QA training programs.
15. Maintain links with professional bodies such as GPhC, MHRA, and SPS.
16. Act as a Releasing Officer for products under the MHRA (Specials) Licence.

This advert closes on Wednesday 28 May 2025.

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