Overview
Hi, I’m Emma, Head of Pharmacy Clinical Trials Aseptic Services Unit. We are looking for a passionate and dynamic Aseptic Services Manager to join our Pharmacy Clinical Trials Aseptic Services Team for our unique and well-established facility. The role is dedicated to clinical trials and you will work as part of the wider Pharmacy Clinical Trials Team. You will have the opportunity to use your knowledge and experience of working in aseptics in the UK and build on this to deliver a range of aseptically dispensed clinical trial medicines.
Responsibilities
* Lead and manage the day-to-day service provided by CTAS, ensuring aseptic preparation of medicines is run in accordance with current guidance and best practice.
* Identify and implement initiatives to reduce financial costs and environmental impact of the CTAS service.
* Maintain a good working knowledge of the Quality Assurance of Aseptic Preparation Services Handbook requirements and the yellow cover guidance documents from SPS; work with the Accountable Pharmacist and Deputy to review changes and implement where required.
* Have a good working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20/EC), Human Medicines (EU Exit) Regulations 2019 and the ICH GCP guideline as applicable to the dispensing of Investigational Medicinal Products (IMPs) for clinical trials or other products (e.g., NIMPs, physiological compounds).
* Ensure the preventative maintenance and environmental monitoring program is undertaken as per SOPs; review paperwork and manage deviations to ensure compliance with standards.
* Oversee ongoing recruitment of staff, induction and management; collaborate with the training team to ensure an effective and competent workforce.
* Ensure CTAS and staff operate to standards of excellence in customer care with a strong patient focus.
* Maintain a comprehensive knowledge of national legislation and recommendations from DoH, MHRA, NHS England, GPhC and RPS relating to aseptic preparation and GMP.
* Facilitate NHS QA inspections, MHRA and sponsor audits as required; communicate complex regulatory information to ensure actions are taken to resolve findings.
* Maintain the Pharmaceutical Quality System (PQS) with the Accountable Pharmacist and ensure staff work according to PQS SOPs; maintain ongoing validation for competency.
* Monitor and record internal and external errors/near misses; implement corrective and preventive actions as part of the Trust’s Incident Monitoring Program.
* Participate at local, regional and national levels to support advancement of Pharmacy Aseptic preparation and related research; engage with regional Aseptic Service meetings or projects as required.
* Ensure staff safety and compliance with Health and Safety regulations relevant to an aseptic unit (e.g., manual handling, First Aid, COSHH, Biocidal Products Regulation).
* Manage accurate financial records, including invoicing, invoice checks and approval for payment.
* Ensure Drug Alerts from MHRA are processed and actions taken within required timeframes.
* Promote high standards of customer care and patient focus within CTAS.
Qualifications
* Essential: Pharmacy Tech or SMT Diploma; PIPC.
* Desirable: PTQA or equivalent; experience in aseptic services; experience in training and supervision; knowledge of GMP and QA as applied to aseptic services; experience managing staff.
* Desirable: Experience working in Clinical Trials; experience in ATMPs; accuracy and attention to detail; good time management and problem-solving skills; ability to liaise and convey information clearly; ability to work in a team and independently; UK professional registration.
Additional Information
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country, providing a wide range of general and specialist clinical services and serving as a base for medical education, training and research. The Trust comprises four hospitals: John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington, and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care and professional relationships with patients and the wider community. We call this Delivering Compassionate Excellence, focusing on compassion, respect, learning, delivery, improvement and excellence.
Please note: This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 ( amended 2020) and requires a Disclosure to be submitted to the DBS to check for any previous convictions.
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