Job summary

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).

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

About us

Oxford University Hospitals NHS Foundation Trustis 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 four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. For more information on OUH please view OUH At a Glance by OUHospitals - Issuu

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.

Job description

Job 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 Trusts 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 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 SOPs for each clinical trial in accordance regulatory standards and each trials 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 Trusts 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.

Person Specification

Pre and In-process Checking Programme

Essential

Pass

Registered Pharmacy Technician holding NVQ level 3 and BTEC

Essential

Pass

Management qualification or similiar

Desirable

Pass

Experience of working in an aseptic unit

Essential

Pass

Experience of working with clinical trials

Desirable

Pass