Aseptic Services Manager for Clinical Trials Aseptic Services Unit Job 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. In your new role, you will have the opportunity to use your knowledge and experience of working in aseptics in UK and build on this to deliver a range of aseptically dispensed clinical trial medicines. If this role is of interest, then please get in touch for an informal chat and/or visit. Main duties of the job

To lead and manage the day to day service provided by CTAS, and ensure that aseptic preparation of medicines is run in accordance with current guidance and best practice. To participate in identifying and implementing initiatives as appropriate to reduce the financial costs and the environmental impact of CTAS service. To have a good working knowledge of Quality Assurance of Aseptic Preparation Services handbook requirements and the yellow cover guidance documents from SPS. To work with the Accountable Pharmacist and Deputy to review the impact of changes to these standards and implementing change where required. To have good working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019 and the International Conference on Harmonisation GCP Guideline (ICH GCP), as applicable to the dispensing of Investigational Medicinal Products for clinical trials or other products. To ensure the preventative maintenance and environmental monitoring program is undertaken as per SOPs, paperwork is received and reviewed and that deviations are managed to ensure compliance with the standards. To be responsible for the ongoing recruitment of staff, induction and management, and collaborate with the training team to ensure an effective and competent workforce. To ensure the CTAS and its staff operate to standards of excellence in customer care and with a strong patient focus.

Detailed job description and main responsibilities

To lead and manage the day to day service provided by CTAS, and ensure that aseptic preparation of medicines is run in accordance with current guidance and best practice, as detailed but not limited to those set out in Quality Assurance of Aseptic Preparation Services Handbook. 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, and are prepared in a safe, efficient and cost effective manner in accordance with departmental SOPs. To maintain a comprehensive knowledge of national legislation and recommendations from the Department of Health, MHRA, NHS England, the General Pharmaceutical Council and Royal Pharmaceutical Society relating to aseptic preparation and Good Manufacturing Practice. To facilitate NHS QA inspections, MHRA, sponsor audits where required, collaborating and communicating complex regulatory information to ensure that action is undertaken to resolve any findings. To work with the Accountable Pharmacist and Deputy to maintain the Pharmaceutical Quality System (PQS), and ensure staff are working according to the Standard Operating Procedures detailed in the PQS. Alongside the Accountable Pharmacist ensure all staff that work in CTAS are trained and competent to perform daily tasks, and that there is an ongoing validation programme in place to demonstrate ongoing competency. To monitor and record internal and external errors/near misses, taking corrective and preventative action if necessary, as part of the Trust’s Incident Monitoring Program. To participate as required at local, regional and/or national levels to support the continuation and advancement of Pharmacy Aseptic preparation and associated research. This may require participation at regional Aseptic Service meetings or projects. To be responsible for the ongoing recruitment of staff, induction and management, and collaborate with the training team to ensure an effective and competent workforce. To be aware of Health and Safety regulations, and how these apply to an aseptic unit; such as, but not limited to manual handling, First Aid, COSHH, Biocidal Products Regulation. To be responsible for accurate financial records, including invoicing, checking of invoices and authorisation of invoices for payment. To be responsible for ensuring that Drug Alerts received from the Medicines and Healthcare Regulatory Authority (MHRA) are processed and any actions taken within a required time frame. To ensure the CTAS and its staff operate to standards of excellence in customer care and with a strong patient focus.

Person specification Qualifications

Pharmacy Tech or SMT Diploma PIPC PTQA or equivalent

Experience

Experience in aseptic services Experience of training and supervision Knowledge of and ability to apply GMP and QA to aseptic services Experience of managing staff Experience working in Clinical Trials Experience working in ATMPs

Personal Skills

Accurate in work and attention to detail

Behavioural

Capable of working under pressure Ability to liaise, explain and convey difficult information and messages to all staff and service users Ability to work in a team and independently

COVID-19 The COVID-19 vaccination remains the best way to protect yourself, your family, your colleagues and of course our patients from the virus when working in our healthcare settings. Whilst COVID-19 vaccination is not a condition of employment , we do encourage our staff to get vaccinated. If you are unvaccinated there is helpful advice and information at Oxfordshire County Council Website where you can also find out more about how to access vaccination. Vacancy Closures Please note, this vacancy may close early if a high volume of applications are received. Probation Period This post is subject to a 6 month probationary period. If you currently hold a contract of employment with the Oxford University Hospitals, this will not apply. This statement does not apply to Medical staff or Executive Appointments. Referencing When providing employment reference details please provide correct work related email addresses so references can be sought promptly when we are looking to progress your application. Your first referee will need to be your line manager, supervisor or clinical lead from your current or most recent post or place of study. Please note that if you have previously worked for the Trust we will require a reference from your last Manager, this information is essential if your offer of employment is to be confirmed. Next Steps Please make sure that you read the job description and person specification, and that your supporting statement reflects this as your application will be judged against these criteria. Candidates selected for interview will be contacted after the short-listing process, usually within 2 weeks. (Please note that shortlisting times vary when applying for a Medical position within the Trust). The majority of correspondence will be via the e-recruitment system; therefore you should check your emails regularly including junk mail folders in web-based email products. Employer certification / accreditation badges You must have appropriate UK professional registration. The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions. Application numbers Please note that this job advertisement will close automatically once the application limit is reached, regardless of whether this occurs before the advertised closing date. Departments and services You can view our departments and services alphabetically. Some areas also have dedicated microsites, which are featured in the linked images below. #J-18808-Ljbffr