Job summary
We are excited to seek two Specialist Technical Officers 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!
You will undertake all technical duties required for the preparation of manufactured injectable pharmaceuticals within the pharmacy aseptic unit, with a particular focus on supporting our growing portfolio of clinical trial studies.
This 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 and exciting opportunity to join our team as we are a designated "pathfinder" site and in the near future we will be moving to a purpose built, off-site aseptic facility which will significantly expand our capacity.
Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS at Risk staff throughout Devon who is able to display recent relevant experience as dictated by the Person Specification.
Main duties of the job
To 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 to ensure patients receive products that are safe to use.
Ensure compliance with current national legislation, the 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.
To supervise the work of Assistant Technical Officers, Senior Assistant Technical Officers, rotational technicians and students in conjunction with the Senior Specialist Technicians.
To assist with the environmental monitoring of the aseptic unit and associated activities
About us
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment team on 01752 432100. We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
Job description
Job responsibilities
To prepare and prioritise cancer chemotherapy, and medicines for injection, using aseptic technique and isolator technology, providing all necessary in-process checks, within the clean room environment, isolated from direct supervision.
To work unsupervised if necessary in the preparation of cancer chemotherapy.
To prepare cancer chemotherapy for intrathecal use according to Department of Health guidelines, local Trust policy and departmental procedures.
To complete the initial check and in-process check of cytotoxic and non-cytotoxic injectables completing the in-house competency assessment and the South West accredited pre and in process checking accuracy accreditation and room supervisor qualification.
To follow carefully all standard operating procedures to ensure all products are made safely and efficiently in accordance with Good Manufacturing Practice Guidelines.
To prepare product documentation using electronic worksheets, with all types of calculations. To use computer software to create product documents and labels.
To participate in the preparation of clinical trials completing all necessary documentation as described in the study protocol.
To assemble the raw materials and consumables required to prepare each individual product, ensuring total segregation of each preparation using a box or tray segregation system as defined in the standard operating procedure.
To complete any environmental monitoring or operator validation tests
To supervise Assistant Technical Officers and Senior Assistant Technical Officers, Technicians and students within aseptic services and clinical trials.
To train and carry out competency assessments of designated aseptic services staff under the guidance of the Senior Pharmacy Technicians.
To organise the workload under the direction of the Senior Pharmacy Technicians.
To prepare the first draft of master product documentation for new products/materials/consumables and the first draft of new standard operating procedures under the direction of the senior Pharmacy Technicians.
To complete, maintain and file all relevant documents, records and reports.
To assist with stock control including the production and checking of routine stock checks and ensuring stock rotation and expiry date checks.
To co-operate and participate in any training and development in aseptic services and clinical trials, attending such study days and courses as necessary for service development.
To clean the pharmacy aseptic suite and support rooms following standard operating procedures and using specific methods of cleaning, ensuring appropriate quality control samples are taken and cleaning logs filled out.
To take part in an on-call emergency duty rota to assist the on-call pharmacist to include, information relating to queries about aseptic services work, preparation of emergency medicines and preparation of scheduled treatments that are unable to be made in advance.
Job description
Job responsibilities
To prepare and prioritise cancer chemotherapy, and medicines for injection, using aseptic technique and isolator technology, providing all necessary in-process checks, within the clean room environment, isolated from direct supervision.
To work unsupervised if necessary in the preparation of cancer chemotherapy.
To prepare cancer chemotherapy for intrathecal use according to Department of Health guidelines, local Trust policy and departmental procedures.
To complete the initial check and in-process check of cytotoxic and non-cytotoxic injectables completing the in-house competency assessment and the South West accredited pre and in process checking accuracy accreditation and room supervisor qualification.
To follow carefully all standard operating procedures to ensure all products are made safely and efficiently in accordance with Good Manufacturing Practice Guidelines.
To prepare product documentation using electronic worksheets, with all types of calculations. To use computer software to create product documents and labels.
To participate in the preparation of clinical trials completing all necessary documentation as described in the study protocol.
To assemble the raw materials and consumables required to prepare each individual product, ensuring total segregation of each preparation using a box or tray segregation system as defined in the standard operating procedure.
To complete any environmental monitoring or operator validation tests
To supervise Assistant Technical Officers and Senior Assistant Technical Officers, Technicians and students within aseptic services and clinical trials.
To train and carry out competency assessments of designated aseptic services staff under the guidance of the Senior Pharmacy Technicians.
To organise the workload under the direction of the Senior Pharmacy Technicians.
To prepare the first draft of master product documentation for new products/materials/consumables and the first draft of new standard operating procedures under the direction of the senior Pharmacy Technicians.
To complete, maintain and file all relevant documents, records and reports.
To assist with stock control including the production and checking of routine stock checks and ensuring stock rotation and expiry date checks.
To co-operate and participate in any training and development in aseptic services and clinical trials, attending such study days and courses as necessary for service development.
To clean the pharmacy aseptic suite and support rooms following standard operating procedures and using specific methods of cleaning, ensuring appropriate quality control samples are taken and cleaning logs filled out.
To take part in an on-call emergency duty rota to assist the on-call pharmacist to include, information relating to queries about aseptic services work, preparation of emergency medicines and preparation of scheduled treatments that are unable to be made in advance.
Person Specification
Knowledge and experience
Essential
- oGood working proven knowledge of current legislation, department of health guidelines and Medicines and Healthcare Regulatory Agency regulations concerning aseptic preparation and manufacture.
- oPrevious demonstrable experience in aseptic preparation
- oDemonstrable practical experience Of Isolator Technology and Laminar Flow cabinets
- oProven understanding of COSHH
- oBasic proven knowledge of Good Pharmaceutical Manufacturing Practice and Good Laboratory Practice
Desirable
- oProven knowledge of analytical techniques and equipment.
- oAttendance on Leeds aseptic preparation and dispensing of medicines course (or equivalent). Training can be provided.
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.
Desirable
- oProven knowledge of Microsoft programmes e.g. word / excel.
- oIn house / southwest accreditations for pre and in process checking. Training can be provided.
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
- oAbility to supervise other staff.
Desirable
- oAbility 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 under pressure.
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 ie handling of cytotoxic drugs.
Person Specification
Knowledge and experience
Essential
- oGood working proven knowledge of current legislation, department of health guidelines and Medicines and Healthcare Regulatory Agency regulations concerning aseptic preparation and manufacture.
- oPrevious demonstrable experience in aseptic preparation
- oDemonstrable practical experience Of Isolator Technology and Laminar Flow cabinets
- oProven understanding of COSHH
- oBasic proven knowledge of Good Pharmaceutical Manufacturing Practice and Good Laboratory Practice
Desirable
- oProven knowledge of analytical techniques and equipment.
- oAttendance on Leeds aseptic preparation and dispensing of medicines course (or equivalent). Training can be provided.
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.
Desirable
- oProven knowledge of Microsoft programmes e.g. word / excel.
- oIn house / southwest accreditations for pre and in process checking. Training can be provided.
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
- oAbility to supervise other staff.
Desirable
- oAbility 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 under pressure.
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 ie 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.
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).
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.
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).
