Specialist Aseptic Services Technician

Job Summary
The Pharmacy Aseptic Service at Great Western Hospital is expanding with the build of a new onsite aseptic unit for the preparation of injectable medicines such as chemotherapy and we're looking to grow our team.

This position is for a full-time 12 month fixed term band 6 Specialist Pharmacy Technician with the Accredited Checking Technician qualification and experience in aseptic services and/or cancer services working to support a team of Assistants, Senior Technicians and Pharmacists who take pride in delivering safe, effective and high quality injectable medicines to our patients at the GWH.

The successful candidate will primarily support the Aseptic Services team in the final accuracy checking and release of high risk injectables purchased from External Specials suppliers including chemotherapy, monoclonal antibodies and parenteral nutrition.

We're looking for a team worker with good interpersonal skills, able to work within a clean room controlled environment with good literacy, numerical and computer skills who may also have previous training and understanding of Good Manufacturing Practice, although training and competency assessment in aseptic skills will be provided.

Main duties of the job
To support the management of the day-to-day service provided by PASU, and ensure that outsourced service and 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 assist the Pharmacy Aseptic Services Senior leadership Team in the safe, effective and efficient provision of high-risk injectables by accuracy checking outsourced ready-to-administer high-risk injectables. As well as co-ordinating and supervising the day-to-day allocation of staff activities in both the outsourced and in-house services.

To ensure staff are undertaking activities following department standard operating procedures and work in accordance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Clinical Practice (GCP)

About Us
Our STAR values - Service, Teamwork, Ambition and Respect - are a golden thread running through everything we do. These values serve as a guiding principle, driving us towards our vision of delivering great joined up services to our local community. Whether at home, in the community, or within the hospital, our goal is to empower individuals to lead independent and healthier lives.

Job Description
Job responsibilities

• To support the management of the day-to-day operational running of the PASU.
• To co-ordinate the daily workload with the PASU ensuring products are supplied to service users in a timely manner.
• To manage and undertake the completion of staff rotas, planning of work duties and staff training objectives ensuring set levels of staffing are maintained.
• Have good knowledge and understanding of the computer systems used to generate documentation such as worksheets, procedures and labels used in aseptic preparation and ensure validation and change control procedures are followed.
• To be able to perform calculations accurately when checking computer generated worksheets
• To complete the daily capacity planner ensuring safe capacity levels for workload and escalating if required.
• To take part in the accuracy checking and final release of products purchased from external Specials suppliers.
• To take part in pre, in-process and final checking of products prepared aseptically by PASU and maintain competence in this area.
• To be able to risk assess and recommend whether a product is fit for purpose, knowing when to refer to the Authorised Pharmacist.
• To be able to ascertain and have knowledge of the stability and formulation requirements of aseptically prepared products including suitability of diluents, volume of diluents, administration routes.
• To manage the ordering of patient specific and batch pre-prepared aseptic products (cytotoxic, high risk injectables and parenteral nutrition) from external Specials suppliers in a timely, efficient and safe manner and ensure all necessary quality assurance checks are completed.
• To liaise and communicate effectively with external Specials suppliers to ensure the Trust is receiving a high quality and efficient service. Where necessary to proactively manage complaints and service improvements.
• To assist in the management of contracts for outsourced patient specific and batch pre-prepared aseptic products (cytotoxic, high risk injectables and parenteral nutrition), and aid in the reporting of key performance indicators.
• To maintain the necessary competencies. These include but are not limited to valid hand washing, gowning, transfer, cleaning, dispensing, operator broth tests, pre & in-process and checking validations.
• To be competent to accurately and consistently participate in the aseptic preparation, ordering and dispensing of high-risk injectables including parenteral nutrition, Systemic Anti-Cancer Treatments (SACT), monoclonal antibodies, Clinical trial IMPs and CIVAs.
• To ensure all PASU staff safely handle, store and dispose of hazardous materials such as cytotoxic drugs, monoclonal antibodies, vaccines and sharps, according to Trust policies, Health and Safety at Work Act and COSHH regulations without further increasing the risk to themselves or their colleagues.
• To undertake regular environmental monitoring and quality control tasks to ensure the PASU environment and product quality remains within specified limits. To act on findings and report any out of specifications to the Accountable Pharmacist.
• To ensure the proper use, maintenance and cleaning of all equipment including pharmaceutical isolators and cleanrooms according to departmental procedures.
• To be responsible for delivering stock control, ordering levels, storage, invoicing and quarantine of medicines. This includes starting materials, consumables and aseptically prepared batch products purchased from external Specials suppliers where delegated by procurement leads.
• To assist in providing financial costing and reports in relation to stock usage, wastage, contracts and workload information.
• Assist with the investigation of deviations, non-conformances, out of specification results and errors, including completion of the relevant paperwork and root cause analysis.
• Assist the Lead and Deputy Lead for Aseptic Services and Accountable Pharmacist with the development, review and implementation of new products, Standard Operating Procedures (SOPs), formal documentation and policies
• To facilitate the induction and on-going training of all PASU staff in outsourced activities, GMP, aseptic preparation and safe working practices.
• To be responsible for the supervision of staff and to undertake assessment and re-validation of staff to ensure a high quality and safe environment is maintained.
• To be involved in the quality management system and attend and present information in regular quality meetings.
• To support the identification and management of risk within the PASU and to escalate identified risks to the senior PASU team.
• To assist the Accountable Pharmacist in the self-inspection audits and yearly Assurance of Aseptic Preparation of Medicines inspection and take an active role in addressing any deficiencies identified.
• To identify, suggest and implement changes in a controlled manner to ensure continuous improvement within PASU.
• To participate in early and late rotas as required by the service
• To participate in all other duties deemed appropriate by the senior team and relevant to the role

Person Specification

Qualifications
Qualifications
Essential

• Current registration with the General Pharmaceutical Council (GPhC) or Science Council if SMT
• NVQ3, BTEC in pharmaceutical science or equivalent
• Accredited Checking Technician qualification
• Knowledge of pharmaceutical technical procedures for specialist area to degree or equivalent level acquired though training

Desirable

• Evidence of post qualification training in Aseptic Services e.g. Leeds University, Aseptic preparation and dispensing of medicines
• Evidence of post qualification training in Cancer services
• NVQ assessor or equivalent qualification
• Pre and In-Process Checking Accreditation
• Product Approval Accreditation or willingness to work towards

Experience
Essential

• Experience working in aseptic or cancer services
• Working knowledge of aseptic services
• Working knowledge of the procurement of pre-prepared aseptic products purchased from external Specials supplier
• Proven stock management and control experience
• Experience in staff supervision
• Experience of staff training and development

Desirable

• Recruitment and selection experience
• Procedure and policy development
• Understanding of legal requirements, procedures, protocols governing clinical trials and GCP
• In-depth technical ability and knowledge in aseptic reconstitution

Additional information

Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab) .

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab) .

UK Registration
Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).