Job responsibilities
1. Aseptic Services Responsibilities:
To lead on the development, implementation and monitoring of pharmacy technicians, practitioners, pharmacy assistants and apprentice pre-registration trainee pharmacy technicians input to Pharmacy Aseptic Services at The Christie NHS Foundation Trust in conjunction with the Aseptic Services Manager.
To co-ordinate and manage all aseptic services technicians, practitioners, pharmacy assistant and apprentice pre-registration trainee pharmacy technician activities to maintain defined service standards.
To regularly monitor the standard of professional work undertaken by aseptic services technicians, practitioners, pharmacy assistants and apprentice pre-registration trainee pharmacy technicians in accordance with local and national competency frameworks.
To oversee stock control within the Aseptic Services Unit. Maintains adequate and appropriate stocks of both medicines and consumables used in the unit ensuring stock rotation and delivering any reports requested on purchase, usage or stock levels.
To attend relevant internal, regional and national meetings to network, develop standards for aseptic services and participate in benchmarking and regional audit.
Participate in continual service improvement to coordinate change across the aseptic service and wider organisation using benchmarking skills to support best practice and quality.
To attend external meetings as necessary, representing the Trust and pharmacy Aseptic Services Unit in a professional manner, for example.
To investigate DATIX incidents pertaining to the Aseptic Services Unit as necessary and to initiate changes to service improvement as a resulting outcome. To actively participate in route cause analysis of incidents, to develop and implement action plans, if necessary, to safeguard against future incidents. To attend ERGs when necessary.
Participate in service risk assessments and take any action necessary to maintain a safe environment, reviewing and updating the risk register for operational technical pharmacy risks.
To attend and contribute to clinical governance programmes, including clinical risk, incident management, investigation and reduction and to ensure compliance with service, Trust and national guidelines.
To actively participate in the MRHA drug recall process, in conjunction with the third party provider, with regard to aseptic service implications and resulting communications with the Trust.
To actively contribute and support the Aseptic Services Manager in the development and implementation of a strategic plan for future initiatives and development of the Aseptic Services Unit.
To develop a framework for pharmacy aseptic technicians to perform the Final Check and Product Approval of aseptically prepared treatments according to local and national standards, following a period of competency-based training and assessment if approved by the Reqional Quality Assurance.
To be a point of contact for issues, queries and concerns from service users.
Any other reasonable duties as requested by the Aseptic Services Manager and Director of Pharmacy.
Manage the aseptic units, in conjunction with the Aseptic Services Manager and their deputy, to ensure the provision of a high quality service.
Involvement in the development and maintenance of the Pharmaceutical Quality System, delegating tasks when appropriate.
Oversight of the Validation Master Plan, ensuring all necessary validations are carried out to the required standard.
Oversight of the Planned and Preventative Maintenance schedule, ensuring the service is maintained to the necessary standard. Maintains an annual schedule to ensure all Planned Preventative Maintenance and planned targets are achieved and work is organised to minimise the impact on production. Operates the Permit to Work system.
Have a thorough and in-depth working knowledge of Good Manufacturing Practice and standards, procedures, legislation or national guidelines relating to the aseptic preparation of medication and clinical trials.
To undertake technical final accuracy check and product approval of aseptically prepared products. To develop competency frameworks to introduce these tasks to other staff and act as course mentor.
Responsible for oversight of workload planning and managing the day to day organisation of aseptic services operated at the Trust, including personal participation as required.
Responsible for ensuring that that the aseptic service adopts and complies with clinical governance strategies including risk management assessments of working practices, reporting of clinical incidents, monitoring and analysis of pharmacy error reporting schemes, intervention monitoring and risk reduction strategies.
Maintains the environmental standards within the Aseptic Service facilities to regional and national standards.
Assesses and collates monitoring results, detecting any trends or alert limits then taking remedial action. Reports results or problems outside the scope of expertise to the Aseptic Services Manager, or their deputy.
Maintains and develop Standard Operating Procedures, ensuring staff adherence and updates. Responsible for authorising deviations from Standard Operating Procedures within the scope of expertise.
Ensures that all operational practices, procedures, records and financial controls comply with applicable legislation such as the Medicines Act, the Misuse of Drugs Act, Health & Safety at Work Act, the Control of Substances Hazardous to Health Regulations and local procedures.
Trained and named on the intrathecal register to undertake appropriate tasks relating to intrathecal chemotherapy services. Co-ordinates and leads both the initial training then re-training of technical staff to maintain adequate numbers of registered technical staff in accordance with local and national guidance..
Participates in the production of all types of aseptically prepared products, demonstrating the necessary high standard of dexterity, accuracy and precision required for aseptic manipulations. Ensures high quality training.
Manages the internal rolling audit program for aseptic services. Participates in external audits from both Regional Quality Control and MHRA, as appropriate. Participates in the preparation of the remedial action plan in response to these audits and ensures the plan is delivered.
To maintain service contracts for equipment and services used within aseptic services. Monitors and annually reviews all service contracts and SLAs.
Monitors the aseptic functionality of the pharmacy computer system, detects and reports any variances to the system manager and, prior to re-use, authorises as satisfactory the results of any remedial action. Provides staff training.
Assists in both the running and the development of the capacity plan. Liaises with other hospitals within the trust to develop a cohesive aseptic service with flexibility to cope with contingency situations.
Understands the operation and control systems of equipment including the air handling unit to be able to decide when permits to work can be signed as satisfactory, and understands the impact of equipment on the quality of the product.
In the case of equipment/ air handling failure, takes responsibility for initiating unit closedown and product recall if necessary in consultation with the Aseptic Services Manager, or their deputy.
Have a thorough and in-depth working knowledge of pharmacy stock control and ordering systems.
Participation in Regional and National aseptic meetings and involvement in training development and initiatives.
Orders pharmaceutical items in the absence of colleagues. Is an authorised signatory for values up to an agreed limit for drugs only.
Ensures the cost-effective use of equipment, consumable supplies and medicines.
Monitors the equipment, reports any faults or damage and ensures timely maintenance and repairs. Liaises with any contractors where necessary, ensuring such personnel follow the required clean room practices.
Liaises with industry representatives to discuss developments relating to pharmaceutical or aseptic related products, ensuring that items are procured at optimum price.
Ensures any new equipment is fully tested, validated, Health & Safety risk assessed , procedures are written, and staff are trained in its appropriate use, before the equipment is introduced
2. Managerial Responsibilities:
To hold extensive leadership skills, being an inspirational role model to the team.
To oversee the management of all aseptic services technicians, practitioners, pharmacy assistants and apprentice pre-registration trainee pharmacy technicians and ensure their compliance to the minimum performance standards.
Ensure the safe and effective operating of pharmacy structures by managing lead pharmacy technicians in all relevant areas, and to ensure compliance with legal, local and national guidelines.
To be responsible for and to oversee, the recruitment of technical and assistant staff into the pharmacy aseptic service in accordance with the Trusts recruitment and selection policies and induction programmes.
To be responsible for, and to oversee, the recruitment of apprentice pre-registration trainee pharmacy technicians in accordance with the Trusts recruitment and selection policies and induction programmes, coordinating with School of Pharmacy and Medicines Optimisation North, Health Education England.
To provide oversight and monitor all delegated rotas for the technical aseptic service, to ensure the most effective deployment of the pharmacy team providing aseptic services at all times.
A full outline of the role is provided within the job description and person specification.
