Job summary
This is a key role essential to the delivery of a comprehensive, efficient and high quality clinical radiopharmacy service to the Trust and external customers. The role includes the manufacture and quality control testing of diagnostic radiopharmaceuticals and involvement in the quality assurance aspects of the radiopharmacy quality management system.
This post holder will need to work to a high degree of accuracy, utilise excellent time management, organisational and communication skills with an adaptable, flexible approach to produce work of a high standard within expected targets. They will need to take an active role in research and clinical trials when required.
The Specialist Radiopharmacy QA Technician will work closely with the Nuclear Medicine and Medical Physics teams to support all aspects of this service.
Main duties of the job
The role includes supporting the Lead Specialist in Radiopharmacy Quality Assurance in delivering a comprehensive Quality Management System for the Radiopharmacy. The key aspects include ensuring that SOP's, policies, and datasheets are regularly reviewed and updated, deviations are fully investigated and reported in a timely manner, change controls are managed appropriately in order to mitigate risk and the environment is free from microbiological and particulate contamination.
Participation in the manufacture and quality control testing of radiopharmaceuticals and supporting the qualification of the new Radiopharmacy facility and associated equipment is also a requirement.
Staff are required to have a flexible approach to working hours. The normal hours of the department are from 04:30 - 15:00 and staff work different shifts to cover the service provision, with start times varying between 04:30 - 09:00 on a rotational basis. There may also be occasions when duties may sometimes have to be performed outside of the normal working hours of the Department e.g., at weekends.
About us
At UHSussex, diversity is our strength, and we want you to feel included to help us always put the Patient First, as shown in our Outstanding for Caring CQC rating. Your uniqueness and experiences will be part of our creative and innovative community where everyone is encouraged to succeed. We have a range of Staff Networks to help break down barriers, and can offer a buddy to help new members settle in. We're proud to be a Disability Confident Employer (Level 2) and a Veteran Aware Trust.
We treat our patients and staff with the same compassion and empathy we expect for ourselves. We're here for them when they need us, and we go above and beyond to meet their needs. This can be seen in our Wellbeing Programme for staff which is extensive and designed to support you when you need it - because we know that to look after others we must first look after ourselves.
As a university trust and a leader in healthcare research, we value learning, teaching and training so that we can be the best that we can be. From the moment you start with us and throughout your career we will help you to grow and develop. We hope that in choosing UHSussex you are choosing a long and happy career where you will be able to see the difference you make and feel valued for all that you do.
We look forward to receiving your application and the start of your journey with UHSussex.
Job description
Job responsibilities
- The post-holder will be required to comply with relevant statutory requirements relating to the manufacture of radioactive medicinal products, including those related to Good Manufacturing Practice as defined in The Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Medicines and Healthcare products Regulatory Agency).
- The post-holder will participate in the rota for the manufacturing and quality control testing of diagnostic and therapeutic radiopharmaceutical products for clinical use and in that capacity will be required to act as a Radiopharmacy Operator, as defined by the Ionising Radiations (Medical Exposure) Regulations, 2017.
- The post-holder will be required to consign radioactive materials to external sites, in compliance with the statutory requirements applying to the transportation of radioactive materials by road.
- The post-holder will participate in the effective operation of the Quality Management System operated by the Radiopharmacy.
- The post-holder will provide support for quality assurance related activities to the Lead Specialist in Radiopharmacy (QA). This will include activities including self-inspection and internal audits, review of progress against defined action plans and monitoring of open quality defect and change control reports.
- The post-holder will be expected to contribute to the routine operation and maintenance of the Radiopharmacy facilities, including undertaking physical and microbiological environmental monitoring and cleaning of the facilities and equipment.
- The post-holder will be expected to provide support to other members of the Radiopharmacy team when required, to allow for flexibility in working patterns to ensure the efficient operation of the Radiopharmacy.
- The post-holder will be required to participate in qualification and validation activities undertaken in the Radiopharmacy, including those related to facilities, equipment, computerised systems and software, processes and starting materials.
- The post-holder will be required to attend regular meetings for Radiopharmacy staff, including quality review meetings.
Job description
Job responsibilities
- The post-holder will be required to comply with relevant statutory requirements relating to the manufacture of radioactive medicinal products, including those related to Good Manufacturing Practice as defined in The Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Medicines and Healthcare products Regulatory Agency).
- The post-holder will participate in the rota for the manufacturing and quality control testing of diagnostic and therapeutic radiopharmaceutical products for clinical use and in that capacity will be required to act as a Radiopharmacy Operator, as defined by the Ionising Radiations (Medical Exposure) Regulations, 2017.
- The post-holder will be required to consign radioactive materials to external sites, in compliance with the statutory requirements applying to the transportation of radioactive materials by road.
- The post-holder will participate in the effective operation of the Quality Management System operated by the Radiopharmacy.
- The post-holder will provide support for quality assurance related activities to the Lead Specialist in Radiopharmacy (QA). This will include activities including self-inspection and internal audits, review of progress against defined action plans and monitoring of open quality defect and change control reports.
- The post-holder will be expected to contribute to the routine operation and maintenance of the Radiopharmacy facilities, including undertaking physical and microbiological environmental monitoring and cleaning of the facilities and equipment.
- The post-holder will be expected to provide support to other members of the Radiopharmacy team when required, to allow for flexibility in working patterns to ensure the efficient operation of the Radiopharmacy.
- The post-holder will be required to participate in qualification and validation activities undertaken in the Radiopharmacy, including those related to facilities, equipment, computerised systems and software, processes and starting materials.
- The post-holder will be required to attend regular meetings for Radiopharmacy staff, including quality review meetings.
Person Specification
Knowledge and Understanding
Essential
- Demonstrable knowledge of GMP
- Understanding of Quality Assurance
Desirable
- Experience in a QA role
- Minimum of 2 years of Radiopharmacy/aseptic experience
Qualifications
Essential
- First degree, or level 6 equivalent in Pharmacy, Chemistry or relevant science discipline
Person Specification
Knowledge and Understanding
Essential
- Demonstrable knowledge of GMP
- Understanding of Quality Assurance
Desirable
- Experience in a QA role
- Minimum of 2 years of Radiopharmacy/aseptic experience
Qualifications
Essential
- First degree, or level 6 equivalent in Pharmacy, Chemistry or relevant science discipline
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).
