Bank Quality Assurance Specialist (Healthcare Scientist) Band 8AinLondoninLondonPUBLISHED MON 10 MAR 2025
As part of our team, you’ll not only take on key responsibilities but also have the opportunity to cultivate the talents of the next generation of healthcare professionals. With your experience, you will train and supervise pharmacists and technicians, making a real impact in their career development. At the Royal Free, we value a diverse workforce; we’re particularly keen to welcome women who might be seeking a fulfilling role that allows for flexibility while maintaining a significant contribution to healthcare. If you’re ready to make a difference in a supportive environment, we’d love to hear from you.
At The Royal Free NHS Foundation Trust, we are passionate about delivering the highest quality care to all our patients. In order to help us achieve this, we are looking for enthusiastic, motivated and committed Quality Assurance Specialist (healthcare scientist) Band 8 A to join our temporary staffing bank.
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The Royal Free London NHS Foundation Trust is a high performing Trust with some of the best clinical outcomes in the country.
The post will incorporate within the Group Clinical Services division to deliver Pharmaceutical QA Services to the trust Pharmacy Manufacturing and Quality Control Units.
To review analytical test methodology for the testing of manufactured products in accordance with pharmacopoeial requirements
To be responsible for operation and control of the Pharmaceutical Quality System (PQS) via the electronic Quality Management System (eQMS) used in support of activities conducted under site MS(specials), MIA(IMP) licenses; to support preparation activities conducted in accordance with exemptions specified in Section 10 of the Medicines Act and in line with the requirements of the Site Master File (SMF) and Quality Manual.
To provide technical support and advice to other departments in the trust and to external customers of the trust.
To Release Sterile and Non-Sterile manufactured products.
To provide QA advice and support necessary for the management of Clinical Trials in the Pharmacy in accordance with the statutory requirements for Good Clinical practice
To maintain a high level of scientific, technical and legal knowledge and expertise.
About us
Royal Free World Class Values
The post holder will offer World Class Care to service users, staff, colleagues, clients and patients alike.
- RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT
To deliver the key targets for the Trust research and development agenda as agreed between the post holder and the Head of Pharmaceutical Quality
To ensure the pharmaceutical quality management system is maintained and developed in accordance with the ML (specials) and MA (IMP) license requirements and in response to changes in regulations and legislation.
To participate in the GMP Internal Audit / self-inspection programme. ensuring audits are conducted, reported and CAPA managed in a timely manner.
To ensure QA requirement for validation master plan are fully completed and documented.
To assist in the review of service contracts and technical agreements with suppliers.
To assist in the review of specifications for raw materials, finished products, packaging materials and labels.
2.Staff Supervision and Training
To participate in the training of Pharmacists, scientists, pre-registration pharmacy graduates, Pharmacy Technicians and student Pharmacy Technicians. Training of personnel external to the trust may also be required.
3.Resource Management
To assist in the planning for equipment procurement and ensure that equipment and plant is adequately qualified and maintained and its performance continuously verified.
4.Research and Development (including Clinical Trials)
To provide support to the development, formulation and validation of new products in response to clinical trial and clinical need and risk management in accordance with client and trust objectives.
To undertake, supervise and give guidance on the preparation of pharmaceutical clinical trial materials used within the Trust.
To review all new trial documentation and assess whether the production of the Investigational medicinal product (IMP) comes under the MA (IMP) license, or is subject to preparation in accordance with exemptions specified in Regulation 37 of the Clinical Trial regulations (SI2004/1. To ensure that all IMP production and preparation is undertaken in compliance with GMP and GCP
5.CLINICAL SERVICES
To provide expert pharmaceutical QA advice on the use of all the trusts manufactured products.
To assess the suitability of unlicensed medicines purchased by the trust and release for use as appropriate.
6.PROFESSIONAL RESPONSIBILITIES
To remain on the relevant Professional register.
To undertake GCP and GMP training as required.
To maintain 100% MAST record.
To act as a role model to all other Pharmacy staff.
To participate in regional training initiatives for manufacturing, preparation, dispensing and QA where applicable.
To always behave in a manner that is professional, positive and polite.
To be accountable for own professional actions.
To maintain awareness of current developments in pharmacy, Radiopharmacy safety, human resources and employment law.
For further information please refer to the attached JD and PS
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