Radiopharmacy Quality Assurance Operator
The Nuclear Medicine department is seeking a dedicated Quality Assurance Operator to join our team and play a key role in supporting Quality Management within the Nuclear Medicine Radiopharmacy.
This position will work closely with the Radiopharmacy management team to support all aspects of Quality Management and ensuring that the department is meeting the standards required of EU Guidelines for Good Manufacturing practice (EU GMP Vol ).
***Preference will be given to internal Trust staff, as well as ‘Priority’ and ‘At Risk’ status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***
This role is subject to job matching for pay grade.
Please note this role is not eligible for sponsorship under the UK Skilled Worker Visa route. Applicants must have the right to work in the UK at the time of the application.
Main duties of the job
You will support the Quality Management team to ensure that the department is complying Good Manufacturing Practice (GMP) and also meeting national regulatory standards and trust policies.
Alongside the Radiopharmacy Managment team you will be responsible for administering the Radiopharmacy and Production Services Pharmacy Quality System (PQS).
You will maintain the document control system on the Quality Management System (QMS).
You will ensure that the Radiopharmacy service is organised in an efficient and timely manner and will organise and assist in meetings, taking minutes.
You will participate in developing and validating quality control (QC) methods and carrying out QC testing of radiopharmaceutical products, such as pH and radiochemical purity (RCP), ensuring these meet required standards.
You will undertake internal audits, reporting the findings to the Quality Systems Manager and monitoring progression of actions to ensure prompt completion through the QMS.
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 manager for this post who will put you into contact with the recruitment team. 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 responsibilities
PRIMARY DUTIES & AREAS OF RESPONSIBILITY
Pulse Quality Management Application
To co-ordinate and manage the day to day and long-term functionality of the Q-Pulse quality management system within the Aseptic Services and Radiopharmacy Database.
To develop, introduce and validate new processes and work streams within Q-Pulse.
To develop, maintain and evaluate standard operating procedures for Q-Pulse.
To coordinate and assist with the training of all Radiopharmacy personnel on the use of Q-Pulse.
To advise the Radiopharmacy management team on the strategy for using the Q-Pulse system.
To attend the Q-Pulse user group and assist with the development and maintenance of the system.
SPECTra
To assist in the validation of SPECTra, analyse data and generate reports from it as required.
To manage passwords and system security for all Radiopharmacy staff.
To coordinate and assist with the the training of all radiopharmacy personnel in the functionality and efficient use of SPECTra.
For further information please see the attached JD & PS
Person Specification
Knowledge and Experience
- Proven understanding of the application of IM&T to a clinical working environment
- Ability to analyse complex data and processes and present to non-specialist staff.
- Ability to troubleshoot and solve problems for a range of IM&T systems.
- Good proven working knowledge of the principles of audit
- Demonstrable experience in QA investigations and SOP management.
- Understanding of GMP, quality management principles and aseptic techniques.
Qualifications
- Proven degree level (or equivalent demonstrable relevant experience) in science related field
- Excellent proven knowledge of MS software e.g. Competent user of Microsoft packages
Apptitude and Abilities
- Ability to communicate with a wide range of people, including technical and other specialist issues to non-specialist staff.
- Excellent written and verbal communication skills
- Excellent organisational skills
- Ability to manage and implement change in a fast-paced environment
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.
£28,392 to £31,157 a yearPer Annum Pro Rata
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