Advanced Specialist Aseptic Services Pharmacist

Job overview

There has never been a more exciting and innovative time to work within aseptic services at The Christie NHS Foundation Trust. An excellent opportunity has become available for a technician with experience and interest in Aseptic Services.

You will be joining our dynamic aseptic team at an exciting and challenging time in developing a first-class aseptic service. The aseptic unit provides an extensive portfolio of Clinical Trials, including Phase 1 and Gene therapy, alongside Early Access Medicines and compassionate use schemes. The unit covers two cleanrooms, one dedicated to Gene therapy, with a total of five negative pressure isolators.

You will work closely with other members of our multi-disciplinary teams to ensure that Christie patients have access to the very latest developments in oncology and haematology medicines. You will become an integral part of our aseptic service, clinical and research teams. The Pharmacy Department is also supporting a number of collaborative projects alongside several research partners and has strong links with the University of Manchester.  Several members of our staff have undertaken post graduate training, research and other secondment opportunities and we are keen to support more.

Have a look at this short video which outlines what it’s like to work at The Christie

https://www.youtube.com/watch?v=xuTC_PsYI8g&ab_channel=TheChristieNHSFoundationTrust

Working from home patterns within the department is in development.

Main duties of the job

For Main Duties of this role:

Please see the Detailed job description and main responsibilities Section.

Detailed job description and main responsibilities

DUTIES AND RESPONSIBILITIES

Leadership

• To act as a professional role model and develop positive relationships with key personnel.
• To promote pharmacy services development within the Trust.
• To be self-motivated and committed to the development of pharmacists, pharmacy technicians and support staff within your area of responsibility.
• To represent the department at Divisional, Trust and external meetings as directed by the Aseptic Services Manager providing information and reporting back all relevant information to the appropriate staff.
• Provide leadership and highly specialised advice on all matters relating to Aseptic Services activities.

Service Development

• To be involved in the contribution of specialist knowledge into the research and evaluation of new products, equipment, devices and methods of work, including clinical trials, analysing and interpreting the requirements for service developments within the Aseptic Services Unit.
• To ensure validation is carried out for all service developments prior to introduction.
• To be involved in ensuring that the Aseptic Services objectives are in line with Trust and departmental strategic development plans.
• Along with the Aseptic Services Manager, be involved in the expansion of existing services and the development of other aseptic services in accordance with the departmental strategic plan.
• To assist the Aseptic Services Manager in the monitoring and maintenance of the capacity plan, business cases and statements of need for products and services. This will involve analysing data, writing reports and presenting findings

Aseptic

• To be competent in the aseptic preparation of medicines.
• To be involved in the Aseptic Verification process.
• To supervise staff working in the ASU and to check the work in accordance with ASU procedures.
• To be involved in ensuring the highest level of professional standards of service are provided from the Trust Aseptic Services Unit encompassing both quality and timeliness of service to patients and staff.
• To perform, and instruct others to perform, complex dose calculations.
• To act as a checker/product approver within Aseptic Services, checking the work of others members of staff in accordance with departmental procedures, throughout aseptic processing.
• To help to ensure that all staff adhere to hygiene and clothing policies associated with their work within the controlled cleanroom environment. This involves strict hand washing procedures and changing into designated cleanroom clothing.
• To ensure all documentation relating to the day to day operation of the ASU is completed correctly and reviewed at regular intervals.
• To understand the key developments around the provision of patient care.
• To be trained and registered to issue intrathecal doses.
• To ensure cost effective use of resources within Aseptic Services to include the review and monitoring of the cleanroom clothing and cleaning / decontamination solution contracts
• To be involved in identifying required equipment and resources and manage the cost effective purchasing of aseptic services equipment, consumables and resources.
• To be involved in the management of aseptic services stock ensuring stock levels.
• To comply with legal and other requirements related to the purchase, supply, use, safe custody and destruction of medicines within pharmacy and other areas of the Trust.
• To be involved in the monitoring of SACT waste and its reduction.
• To be involved in the development and management of software systems ensuring they are risk assessed and validated.
• Supervise the preparation of medicinal products made under section 10 of the medicines act 1968 and ensure compliance with ‘Quality Assurance of Aseptic Preparation Services’ to provide products that are fit for their intended use, along with clinical trial preparations.
• To coordinate with the senior technicians, the daily workload of medicines for injection to the wards and departments taking into account clinical priority, financial expediency and the capacity plan for the unit.
• Ensure all production operations are carried out according to pre-established Standard Operating procedures and in accordance with Good Manufacturing Practice.
• Responsible for the validation of the new pharmacy electronic worksheet system, in conjunction with the Aseptic Services Manager and their deputy.
• Contribute to the development of products and services, with the Aseptic Services Manager and their deputy.
• Liaise with the Aseptic Services Manager and their deputy for long term strategic development of Aseptic Services.
• Assist with the support and running of the Pharmacy Quality Management System (QMS), internal and external audits.
• Contribute to work on a business case for a new / significant refurbishment of the aseptic unit, and implementation of the resultant plans.
• To be involved is the compilation and review of COSHH documents in line with any changes, and compliant with COSHH (1988) Regulations.
• To be involved is the compilation and review of Stability documents in line with any changes.
• Assist in ensuring the unit is fully compliant with the requirements of the executive letter EL(97)52 issued by the department of health.
• Assist in ensuring the department is fully compliant with the requirements associated with the regulation of clinical trials.
• To contribute to and participate in practise research initiatives within the department.

Policy

• To be involved in the compilation and review of Aseptic Services procedures in line with any changes in legal and ethical policy, Trust developments and local and regional guidance as well as departmental working arrangements.
• To be involved in ensuring the adherence and upholding of Trust and departmental policies and procedures by the Aseptic Services staff.
• To ensure confidentiality is maintained at all times.

Clinical Governance

• To ensure that Quality Assurance standards are maintained in accordance with national, regional and local requirements.
• To assist the Aseptic Services Manager and their deputy in assigned audit activities and produce written reports and statistical information with identified action.
• To be involved, along with the Aseptic Services Manager and their deputy, in ensuring that the annual validation activities are carried out.
• To help to ensure staff within the ASU work within the policies and procedures in order to provide a safe, efficient, patient centred aseptic service.
• To help to ensure that all quality exceptions are documented and appropriate action is taken to resolve any issues raised.
• To assist the Aseptic Services Manager and their deputy to maintain systems which monitor, evaluate and report aseptic service errors and incidents and implement effective CAPAs.
• To be involved in ensuring the aseptic services support the developments of other pharmacy services and comply with relevant statutory and ethical guidance by taking an active role in departmental meetings.
• Ensure appropriate change control processes are followed and authorise changes to any existing product/process or the implementation of any new product or process.

Please see the Person Specification Document Attached for further responsibilities.