Overview
The MHRA licensed 'Specials' pharmacy manufacturing unit is based at the Royal Stoke University Hospital and is a modern purpose-built unit within the hospital. The service encompasses the manufacture of sterile products, and the production of over‑labeling and re‑packaging products, supplying both the trust and external organisations. The quality team are responsible for ensuring compliance with MHRA rules and guidelines and also supporting the manufacturing activities within the Pharmacy Technical services production team and the Radiopharmacy service at UHNM.
Responsibilities
* Assist in the operation, maintenance and development of the Pharmacy Quality Management Systems (PQMS) meeting the changing requirements of the department, the Trust and external regulators.
* Assist in ensuring compliance with the terms of the Medicines and Healthcare Products Regulatory Authority (MHRA) Manufacturer's 'Specials' Licence, ICH and other national guidelines related to pharmaceutical manufacturing and reconstitution or repackaging activities.
* Support PQMS including electronic and paper-based documentation systems ensuring compliance to the requirements of MHRA GxP data Integrity.
* Support the routine environmental monitoring of cleanroom facilities.
* Support the future development of the Pharmacy Services delivered to patients across the organisation, in line with the Directorate Business Plan and the Trust Vision and Strategic Objectives.
* Monitor Key Performance Indicators and support the development of performance dashboards for pharmacy technical services.
* Participate in appropriate rotas, including weekend and bank holiday working.
Qualifications
* Extensive and recent experience of Pharmaceutical Quality Management systems, e.g., change control, deviation investigations, and CAPA management.
* Band 5 role requires this experience; band 4 may be offered to applicants with little or no experience, with robust objectives to progress to band 5 within 2 years.
* Excellent organisational, communication and digital skills, high attention to detail, independence and the ability to work on own or as part of a team.
Equal Opportunity
We are committed to equality of opportunity and welcome applications from everyone regardless of ethnicity, disability, gender, age, faith or sexual orientation. Appointment will be based on merit alone.
Flexible working will be considered in line with Trust policies.
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