University Hospital of North Midlands NHS Trust
We are looking to recruit an enthusiastic and motivated new member of staff to join our well-established Quality team within Technical Services.
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 labelling and re-packaging products, supplying both the trust and external organisations. The quality team is 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.
The role is required to support the further development of the service.
Main Duties of the Job
* 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 with the requirements of MHRA GxP data integrity.
* Support the routine environmental monitoring of cleanroom facilities, responsible for review and trending of data produced.
* Support the future development of the Pharmacy Services delivered to patients across the organisation. This is 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.
About Us
University Hospitals of North Midlands NHS Trust is one of the largest and most modern in the country. Based across two sites, Royal Stoke in Stoke-on-Trent and County Hospital in Stafford, we are proud to serve around three million people and we're highly regarded for our facilities, teaching, and research. We are the specialist centre for major trauma for the North Midlands and North Wales.
All of our employees make a valuable contribution regardless of role here at UHNM and we are proud of our wide range of development packages aimed at ensuring that everyone has the opportunity to fulfil their true potential.
UHNM creates and encourages a culture of inclusion, providing equal opportunities for career development that are fair and transparent. We are committed to being a diverse and inclusive employer and foster a culture in which all staff feel valued and respected. In return, we ask all of our employees to make a commitment to the values, co-created by our staff, patients, and carers, and that unite us as a Trust.
At University Hospitals of North Midlands NHS Trust we know that investing in, supporting, and developing our staff has a direct impact on the quality of care that we deliver. Our employees are as important as our patients and the population that we serve.
Job Responsibilities
To achieve this, for the band 5 role you will need to have extensive and recent experience of Pharmaceutical Quality Management systems, for example, change control, deviation investigations, and CAPA management. This role may be offered to applicants with little or no experience with robust objectives being set to be achieved to progress to Band 5 level (Target within 2 years). Applicants should also be able to demonstrate excellent organisational, communication, and digital skills and a high degree of attention to detail and the ability to work on their own or as part of a team.
Person Specification
Essential Qualifications
* NVQ3 in Pharmaceutical Sciences OR Level 3 Science Manufacturing Technician (SMT) in Pharmaceutical Science OR A degree level qualification in the chemical, biological or pharmaceutical sciences.
* Registered, or eligible to be registered, with the GPhC, Science Council (SMT), Royal Society of Chemistry, Royal Society of Biology or Royal Pharmaceutical Society.
* Registered Quality Controller (MGPS).
* Relevant additional training in GMP / Pharmacy Technical Services.
Knowledge, Skills, Training and Experience
* Extensive and recent experience of Pharmaceutical quality systems. For example, change control, deviation investigations, and CAPA management.
* Knowledge of cleanroom design and functioning.
* Experience of cleanroom environmental monitoring methods and ability to review and analyse trend data.
* High standard of oral and written (including report writing) communication skills with attention to detail.
* Ability to work to standard operating procedures.
* Experience of training staff.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
University Hospital of North Midlands NHS Trust
Dep Quality Manager- Pharmacy Technical Services
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