Oxford University Hospitals NHS Foundation Trust
The Clinical Trials Aseptic Services Unit (CTASU) is responsible for providing aseptically prepared clinical trial doses for patients across different specialities within the Trust and maintaining up to date documentation according to Good Clinical Practice (GCP).
The main role of this post is to supervise and manage the day to day service provided by CTASU and to ensure that aseptic preparation of medicines is run in accordance with current guidance and best practice.
The post holder will support the Aseptic Services Manager and Accountable Pharmacist and will assist in the day to day management of staff and activities associated with aspects of aseptic preparation in order to support the needs of patients and meet the standards of Good Manufacturing Practice (GMP).
Main duties of the job
Core Role
* To lead the Aseptic Services Team in the day to day management of workload in CTASU.
* To undertake accuracy checking of aseptically prepared medicines and raw materials.
* To maintain personal expertise, skills and necessary knowledge of the technical aspects of aseptic dispensing.
* To undertake reviews of batch worksheets used in aseptic dispensing.
* To regularly review departmental records including training logs, equipment logs, and environmental monitoring logs.
* To assist in the training of staff and support the re-validation of staff competencies.
* To support the development and commissioning of new equipment, processes or facilities through agreed SOPs and change control procedures.
* To be responsible for the preparation of rotas for staff and to ensure effective deployment of staff.
* To attend regular meetings to discuss and improve the Pharmaceutical Quality System (PQS).
* To manage the environmental monitoring programme and to trend and action any results that fall out of specification.
* To line manage technical CTASU staff.
Job responsibilities
Main Tasks and Responsibilities
To lead and manage the day-to-day service provided by CTASU, ensuring that aseptic preparation of medicines is run in accordance with current guidance and best practice.
To provide cost-effective delivery of high quality aseptic pharmaceuticals, which are fit for their intended purpose to patients of the Trust and other external customers of the service.
To maintain a comprehensive knowledge of national legislation and recommendations relating to aseptic preparation and Good Manufacturing Practice.
To ensure compliance with relevant standards for the operation and management of Clinical Trials, including ICH-GCP and GMP.
Person Specification
Minimum Requirements:
* Registered Pharmacy Technician holding NVQ level 3 and BTEC.
* Management qualification or similar.
* Experience of working in an aseptic unit.
* Experience of working with clinical trials.
* 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.
Oxford University Hospitals NHS Foundation Trust
£37,338 to £44,962 a year per annum pro rata.
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