Job Summary
We are excited to seek a Specialist Technical Officer to join our pharmacy aseptic services team at University Hospitals Plymouth NHS Trust. If you are enthusiastic, motivated and dynamic we want to hear from you! The role requires you to work closely with the pharmacy departments well–established and dedicated clinical trials team to facilitate the set up, maintenance, preparation and delivery of investigational medicinal products (IMPs) for a range of phase 1 to phase 4 studies. This is a unique opportunity as we are a designated "pathfinder" site and will soon move to a purpose built off‑site aseptic facility which will significantly expand our capacity. Sponsorship is not available for this position.
Responsibilities
* Undertake technical duties in the preparation of systemic anti‑cancer therapy (SACT) and injectable clinical trials within the Pharmacy Aseptic Unit ensuring all products are prepared following quality guidelines for patient safety.
* Ensure compliance with current national legislation, International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidance and the UK Policy Framework for Health and Social Care Research (2023) in the conduct of clinical research.
* Supervise the work of Assistant Technical Officers, Senior Assistant Technical Officers, rotational technicians and students in conjunction with the Senior Specialist Technicians.
* Assist with the environmental monitoring of the aseptic unit and associated activities.
* Prepare and prioritise cancer chemotherapy and other medicines for injection using aseptic technique in laminar airflow cabinets or isolator technology, providing all necessary in‑process checks within the clean room environment, isolated from direct supervision.
* Work unsupervised, if necessary, in the preparation of cancer chemotherapy and other medicines for injection.
* Supervise the preparation of aseptically prepared injectable medicines and complete the cleanroom supervision in pharmacy technical services accreditation provided by Pharmacy Workforce Development SouthWest.
* Prepare cancer chemotherapy for intrathecal use according to Department of Health guidelines, local Trust policy and departmental procedures.
* Complete the initial check of cytotoxic and non‑cytotoxic injectables, completing the in‑house competency assessment and the Pharmacy Workforce Development SouthWest accredited pre‑and in‑process checking accuracy accreditation.
* Follow carefully all standard operating procedures to ensure all products are made safely and efficiently in accordance with Good Manufacturing Practice Guidelines.
* Complete any environmental monitoring or operator validation tests and assist in the planning of new and ongoing validations of colleagues.
* For further details please see attached JD&PS.
Person Specification
Knowledge and experience (Essential)
* Good working proven knowledge of current legislation, Department of Health guidelines and Medicines and Healthcare Regulatory Agency regulations concerning aseptic preparation and manufacture.
* Previous demonstrable experience in aseptic preparation.
* Demonstrable practical experience of Isolator Technology and Laminar Flow cabinets.
* Proven understanding of COSHH.
* Basic proven knowledge of Good Pharmaceutical Manufacturing Practice and Good Laboratory Practice.
Knowledge and experience (Desirable)
* Proven knowledge of analytical techniques and equipment.
* Attendance on Leeds aseptic preparation and dispensing of medicines course (or equivalent).
Qualifications (Essential)
* Proven NVQ Level 3 in pharmacy services aseptic elements or equivalent e.g. Science Manufacturing Technician or equivalent demonstrable experience.
* In‑house competency assessments in areas of specialist work for the assembly, preparation of documentation and preparation of all products.
Qualifications (Desirable)
* Proven knowledge of Microsoft programmes e.g. Word / Excel.
* In‑house / SouthWest accreditations for pre‑and in‑process checking.
Aptitude and abilities (Essential)
* Good written and verbal communication skills with ability to demonstrate fluency, clarity and effectiveness.
* Good training skills.
* Ability to work as an individual or part of a team.
* Mathematical ability.
* Ability to manage own time effectively to meet deadlines.
* Ability to motivate self.
* Ability to supervise other staff.
Aptitude and abilities (Desirable)
* Ability to motivate others.
Disposition, attitude and motivation (Essential)
* Ability to use own initiative and take personal responsibility.
* Honest and reliable.
* Willingness to adapt to change.
* Willingness to co‑operate and get on well with others.
* Ability to cope within a busy environment.
Other factors (Essential)
* Commitment to participate in the on‑call emergency duty rota, assisting the pharmacist.
* Ability to work late nights if required and bank holidays on rota.
* Willingness to adapt to special requirements e.g. handling of cytotoxic drugs.
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).
Employer name: University Hospitals Plymouth NHS Trust
Address: Derriford Hospital Plymouth, Pharmacy Dept, Level 5, Derriford, Plymouth, PL6 8DH
Employer's website: https://www.plymouthhospitals.nhs.uk/
#J-18808-Ljbffr