Job responsibilities
Technical:
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 perform pre and in-process checks of aseptically prepared products having undergone the appropriate accreditation.
To be responsible for ensuring that all medicines and consumables are stored appropriately.
To be responsible for ensuring finished products are transported appropriately according to any physical and regulatory requirements.
To be responsible for ensuring 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 be responsible for 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 CTAS.
To liaise with external and internal suppliers of stock, consumables, equipment etc.
To be responsible for the preparation of rotas for CTAS 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 CTAS, and effectively plan and implement changes and improvements to the CTAS.
To support the development and commissioning of new equipment, processes or facilities through agreed SOPs and Change Control procedures.
Regulatory:
- Ensure ongoing compliance of preparation, dispensing, and testing activities with GMP principles, minimising patient risk.
- Support internal and external audits of the clinical trial aseptic services to ensure legislative compliance and address any deficiencies identified.
- Develop and manage action plans to address findings from internal and external audits, in collaboration with relevant stakeholders such as the MHRA, Regional Quality Controller and senior pharmacy staff.
- Support the development of business cases for the enhancement of quality management services.
- Assist in coordinating and maintaining key performance indicators (KPIs) to monitor quality standards and regulatory compliance.
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.
- 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 of Harmonisation GCP Guideline (ICH GCP) as applicable to the dispensing of Investigational Medicinial Products for clinical trials or products e.g. physiological compounds given to study subjects.
- 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.
Clinical Trials:
To ensure all CTAS 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 CTAS staff have appropriate ICH-GCP training.
To ensure compliance with clinical trial protocols and regulations regarding investigational medicinal products (IMPs) and clinical trial supplies.
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 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.
Quality and Risk Management:
- Coordinate the management of QMS documentation (Change Controls, Deviations, Investigations, CAPA, Risk Assessments) and ensure proper recording and investigation of errors, incidents, and complaints.
- Co-ordinate the management & updating of SOPs, Logs and controlled documents.
- Conduct routine risk assessments on outsourced aseptic products and unlicensed medicines before approval for purchase.
- Coordinate with OxPQAs and the Aseptic Services Manager to execute VMP actions and internal competencies, to ensure continued compliance with standards.
- To support and manage the developmemt and commissioning of new equipment and software, processes or facilities through agreed SOPs and Change Control procedures.
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 CTAS, ensuring that training folders are up to date and valid.
To support the Pre and In Process checking programme for technical staff in the CTAS, in liaison with the Aseptic Unit Manager and 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 CTAS staff are trained and competent and comply with mandatory training requirements.
To work with the technician training team to ensure all CTAS staff are released for mandatory training, and CTAS staff contribute as required to training and competency assessment of pharmacy staff as required.
Alongside the Aseptic Services Manager and 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.
- Support and conduct ongoing competency/validation checks.
Management:
To be responsible for the supervision and day to day management of staff within the CTAS.
To line manage technical CTAS staff and undertake annual appraisal
To ensure all staff in the CTAS 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.
Professional:
- Lead by example, maintaining high professional standards, and fostering a culture of quality and patient safety.
- To hold membership of professional body, to undertake and maintain CPD as required
General Responsibilities:
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 quality issues, queries and concerns.
To participate in week day service starting at 07:00, weekend, evening and bank holiday working according to the rota
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.
Any other reasonable duties as requested by the Clinical Director of Pharmacy and Sterile Services or line manager.
Liaises with:
- Internal: Pharmacy Clinical Trials Team, Oxford Pharmacy Quality Assurance Team wider Pharmacy Team, Trust Finance and Procurement Team, Research and Development Staff including Principal Investigators and Research Nurses, Estates, Soft FM Managers
- External: SPS Regional Quality Assurance, Clinical Research Associates/Organisations, sponsors of clinical trials, external suppliers and contractors.
