Specialist Aseptic Services Technician

Job description

Job responsibilities

1. To support the management of the day-to-day operational running of the PASU.

2. To co-ordinate the daily workload with the PASU ensuring products are supplied to service users in a timely manner.

3. To manage and undertake the completion of staff rotas, planning of work duties and staff training objectives ensuring set levels of staffing are maintained.

4. 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.

5. To be able to perform calculations accurately when checking computer generated worksheets

6. To complete the daily capacity planner ensuring safe capacity levels for workload and escalating if required.

7. To take part in the accuracy checking and final release of products purchased from external Specials suppliers.

8. To take part in pre, in-process and final checking of products prepared aseptically by PASU and maintain competence in this area.

9. To be able to risk assess and recommend whether a product is fit for purpose, knowing when to refer to the Authorised Pharmacist.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. To ensure the proper use, maintenance and cleaning of all equipment including pharmaceutical isolators and cleanrooms according to departmental procedures.

19. 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.

20. To assist in providing financial costing and reports in relation to stock usage, wastage, contracts and workload information.

21. Assist with the investigation of deviations, non-conformances, out of specification results and errors, including completion of the relevant paperwork and root cause analysis.

22. 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

23. To facilitate the induction and on-going training of all PASU staff in outsourced activities, GMP, aseptic preparation and safe working practices.

24. 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.

25. To be involved in the quality management system and attend and present information in regular quality meetings.

26. To support the identification and management of risk within the PASU and to escalate identified risks to the senior PASU team.

27. 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.

28. To identify, suggest and implement changes in a controlled manner to ensure continuous improvement within PASU.

29. To participate in early and late rotas as required by the service

30. To participate in all other duties deemed appropriate by the senior team and relevant to the role

Person Specification

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

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).

Employer details

Employer name

Great Western Hospitals NHS Foundation Trust

Address

Great Western Hospital

Marlborough Road

Swindon

SN3 6BB

Employer's website

https://www.gwh.nhs.uk/ (Opens in a new tab)