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Oxford University Hospitals NHS Foundation Trust
About
The Oxford University Hospitals NHS Foundation Trust (OUH) is one of the largest acute teaching Trusts in the UK, with a national and international reputation for the excellence of its services and its role in teaching and research.
Find out more about the Trust on their web-site at www.ouh.nhs.uk
Watch how OUH goes about delivering compassionate excellence on the ouhnhs YouTube channel
Deputy Aseptic Services Manager
Closed for applications on: 7-Aug-2024 00:02
Vacancy status: Closed
Closed for applications on: 7-Aug-2024 00:02
Key details
Location
- Site
- CTASU, Churchill Hospital
- Address
- Old Road
- Town
- Oxford
- Postcode
- OX3 7LE
- Major / Minor Region
- Oxfordshire
Contract type & working pattern
- Contract
- Permanent
- Hours
- Full time - 37.5 hours per week (1 in 6 weekends)
Salary
- Salary
- £35,392 - £42,618 per annum pro rata
- Salary period
- Yearly
- Grade
- (NHS AfC: Band 6)
Specialty
- Main area
- Pharmacy Research
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research.
The Trust comprises of four hospitals - the 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 we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence. These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel.
Many of our recruitment programmes use Value Based Interviewing to identify those who have the skills we seek, who share our values and who are able to deliver compassionate excellence from the outset. We know that this makes a significant difference to your job satisfaction and above all the outcomes and experience of our patients and their families. For more information about our Values and Value Based Interviewing please visit www.ouh.nhs.uk/about/vision-and-values
Job overview
PREVIOUS APPLICANTS NEED NOT APPLY
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).
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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
Working for our organisation
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. Find out more here www.ouh.nhs.uk
The Trust comprises four hospitals - the 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 we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence. These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel
Detailed job description and main responsibilities
Main Tasks and Responsibilities To lead and manage the day-to-day service provided by CTASU, 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 participate in identifying and implementing initiatives as appropriate to reduce the financial costs and the environmental impact of CTASU 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 Aseptic Services Manager, Accountable Pharmacist and Deputy to review the impact of changes to these standards and implementing change where required. 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 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 eg NIMPs, physiological compounds given to study subjects. 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 Aseptic Services Manager, 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 Aseptic Services Manager and Accountable Pharmacist ensure all staff that work in CTASU are trained and competent to perform daily tasks, and that there is an ongoing validation programme in place to demonstrate ongoing competency. To ensure the preventative maintenance and environmental monitoring programme is undertaken as per SOPs, paperwork is received and reviewed and that deviations are managed to ensure compliance with the standards. 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 Programme. To support in 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 CTASU and its staff operate to standards of excellence in customer care and with a strong patient focus. |
Technical role:
To maintain personal expertise, skills and necessary knowledge of the technical aspects of aseptic dispensing.
To provide specialist technical advice to service users as necessary e.g. suitability of diluents, volume of diluents, administration routes and stability data.
To partake in the rota where required, and perform specific tasks related to the preparation of an aseptic product such as completion of product worksheets, assembly of medicines and consumables, aseptic dispensing, packing prepared medicines for transport.
To perform pre and in-process checks of aseptically prepared products having undergone the appropriate accreditation.
To ensure finished products are transported appropriately according to any physical and regulatory requirements.
To ensure clean room and isolator cleaning standards, and to participate in the clean room/isolator cleaning rota as required.
To be responsible for ensuring that expiry date and stock level checks are carried out.
To ensure maintenance of departmental records including staff training, environmental monitoring, cleaning, maintenance logs and worksheets.
To work collaboratively with Pharmacy Purchasing and Distribution Unit (PPDU) and OUH procurement team to oversee purchasing and distribution for the CTASU.
To liaise with external and internal suppliers of stock, consumables, equipment etc.
To be responsible for the preparation of rotas for CTASU staff and collaborate with other operational managers to always ensure the most effective deployment of staff.
To identify and monitor the needs of service users and CTASU, and effectively plan and implement changes and improvements to the CTASU.
To support the development and commissioning of new equipment, processes or facilities through agreed SOPs and Change Control procedures.
Management:
To be responsible for the supervision and day to day management of staff within the CTASU.
To line manage technical CTASU staff.
To ensure all staff in the CTASU are appraised at least annually in line with OUH policy, and personal development plan and participate in Continuous Professional Development, including competency frameworks as appropriate.
To ensure staff maintain statutory and mandatory training to meet Trust requirements.
To work with the Lead Pharmacist for Education and Training and other senior staff to ensure individual training and educational needs of staff are identified and met through a programme of Continuous Professional Development; including the use of competency frameworks where appropriate.
Clinical Trials
To ensure all CTASU staff are in compliance with relevant standards for the operation and management of Clinical Trials, including ICH-GCP and GMP.
To ensure all members of the CTASU staff have appropriate ICH-GCP training.
To work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and EU directive relating to Clinical Trials.
To communicate with Investigators, Research Nurses, Trust R&D, Sponsors, Clinical Research Associates and Pharmacy staff during the set-up and running of a clinical trial.
To oversee the production, implementation and review of detailed written pharmacy guidance and SOP’s for each clinical trial in accordance regulatory standards and each trial’s protocol.
To ensure clinical trial protocols are followed during dispensing of clinical trial investigational medicinal products and other drugs included in the protocol.
To maintain clinical trial filing systems and drug accountability documentation for clinical trials.
To support the training of medical, nursing and pharmacy staff in all aspects of handling drugs in clinical trials.
To liaise with other centres for clinical research to ensure common standards of practice.
To assist in the development of Pharmacy policies and procedures to support the delivery of clinical trials involving medication and related substances.
Teaching and Training
To be an accredited Pre and In Process Checker
To support in the planning, writing and delivery of training programmes for staff in CTASU, ensuring that training folders are up to date and valid.
To support the Pre and In Process checking programme for pharmacy technicians in the CTASU, in liaison with the Pharmacy Education and Training Team.
To co-ordinate the training for rotational staff such as clinical trial team, cancer team, pre-registration technician and pre-registration pharmacists.
To work closely with the Pharmacy Education and Development team to ensure all CTASU staff are trained and competent and comply with mandatory training requirements.
To be aware of training and competency assessment of pre-registration pharmacists, diploma pharmacists, student pharmacy technicians and apprentices, and participate in their training and competency assessment as required.
To work with the technician training team to ensure all CTASU staff are released for mandatory training, and CTASU staff contribute as required to training and competency assessment of pharmacy staff as required.
General responsibilities
To maintain registration with General Pharmaceutical Council and uphold the professional standards
To ensure confidentiality is maintained at all times.
To use experience and clinical judgment to assist in problem solving and trouble-shooting.
To be professionally accountable for actions and advice.
To collect evidence to deal with complaints in accordance with the Trust’s complaints policy.
To be first point of contact for operational issues, queries and concerns.
To represent CTASU at departmental and Trust meetings.
To participate in week day service starting at 07:00, weekend, evening and bank holiday working according to rota.
Any other reasonable duties as requested by the Clinical Director of Pharmacy and Sterile Services or line manager.
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.
Nursing and Midwifery: For candidates applying from outside the UK: Please be advised that we work in partnership with Envertiz who will be managing your recruitment therefore by applying you are consenting to us passing your contact details and application to Envertiz so they can manage your recruitment and on-boarding. If you do not consent to this, please do not apply.
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.
No unsolicited recruitment agency telephone calls or emails.
Applicant requirements
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.
Person specification
Pre and In-process Checking Programme
Essential criteria
- Pass
Registered Pharmacy Technician holding NVQ level 3 and BTEC
Essential criteria
- Pass
Management qualification or similiar
Desirable criteria
- Pass
Experience of working in an aseptic unit
Essential criteria
- Pass
Experience of working with clinical trials
Desirable criteria
- Pass
Further details / informal visits contact
- Name
- Lewis Whyte
- Job title
- Aseptic Services Manager
- Email address
- [email protected]
- Telephone number
- 01865 572166
No longer accepting applications
Sorry, this vacancy is no longer accepting applications.
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