19631BR
School of Medicine
Managerial, Professional and Specialist Staff – MPSS
Advert
Deputy Radiopharmacy Production Manager
Wales Positron Emission Tomography Imaging Centre (PETIC)
Clinical Innovation Hub - School of Medicine
We have an exciting opportunity for an enthusiastic, highly motivated individual, with attention to detail and a flexible attitude to work, to join our team of experts who produce radiopharmaceuticals to Good Manufacturing Practices (GMP) standards in a purpose designed aseptic facility.
This role is to cover maternity leave and will be fixed term for 12 months. This post can also be offered as a secondment opportunity to Cardiff University employees.
In this role you will be a key member of PETIC’s GMP Team and will be responsible for PET GMP Production activities and will assist the Head of Radiopharmacy Production in managing the production team delivering these activities. The post holder will also support the R&D team in delivering their activities.
You will also participate in an active rota of production and dispensing and quality control of radiopharmaceuticals, operating a range of automated and manual radiochemical synthesis.
You will be involved in a wide range of tasks, assisting in all aspects of operating and maintaining the facility to GMP standards, including equipment and laboratory maintenance, environmental monitoring, incoming materials management, and stock control. This post provides an opportunity to develop a range of skills and acquire technical expertise in a range of equipment. You will also participate in completion of GMP documentation for all aspects of production and quality control.
The Wales Research and Diagnostic PET Imaging Facility is a state-of-the-art PET centre. Equipment includes an IBA18/9 cyclotron with a range of targets, Gravatom hot cells hosting Fastlab and Trasis radiochemistry systems, automated dispensing systems and a fully equipped quality control laboratory with (Radio-)chromatography equipment, Multi-channel Analysis, Endotoxin and Gas Chromatography.
This post is full-time (35 hours per week), fixed term/secondment for 12 months to cover maternity leave.
Salary: £40,247 - £45,163 per annum (Grade 6)
If you would like to know more about this position, then please contact Syed Bukhari on 02920 742005 or via his email BukhariS4@cardiff.ac.uk
Please be aware that the typical working day will begin between 07:00am- 09.00am, which will be dependent upon the GMP production rota. However, there may also be a rare occasion to work flexibly with a possible start time as early as 4.00am or on a Saturday if there is a critical business need.
Date advert posted: Tuesday, 18 February 2025
Closing date: Tuesday, 11 March 2025
Please be aware that Cardiff University reserves the right to close this vacancy early should sufficient applications be received.
Cardiff University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds. We therefore welcome applicants from all sections of the community regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. In supporting our employees to achieve a balance between their work and their personal lives, we will also consider proposals for flexible working or job share arrangements.
Applications may be submitted in Welsh, and an application submitted in Welsh will not be treated less favourably than an application submitted in English.
Job Description
Support the University within the Wales Research and Diagnostic PET Imaging Centre (PETIC), carrying out supporting work, providing advice, guidance and support, and leading projects within this area.
To deputise for the Head of Radiopharmacy when required.
Duties and Responsibilities
Key Duties
* Provide professional advice and guidance on PETIC’s GMP processes and procedures to internal and external customers that will have institute wide impacts, using judgement and creativity to suggest the most appropriate course of action where appropriate, and ensuring complex and conceptual issues are understood.
* Assist and support the Head of Radiopharmacy Production in the management of PETIC’s GMP production team and compliance with Good Manufacturing Practice and the Ionising Radiation Regulations.
* Assist with scheduling and participate in all tasks related to the running of the GMP cleanroom, including environmental monitoring.
* GMP compliant day-to-day production and documentation of PET radiopharmaceuticals, ensuring products are produced, stored and transported appropriately to ensure they are fit for clinical use.
* Review and propose changes to Standard Operating Procedures and systems of work in order to ensure compliance within current standards of GMP, Quality Assurance, transport, waste management and radiation safety.
* Participate in PETIC’s Non-conformance and Corrective/Preventative Action process resolving issues within the required timeframe.
* Assist in the management of PETIC’s asset register ensuring all equipment is introduced, validated, calibrated, and maintained in accordance with defined schedules and processes.
* Assist in the maintenance and upkeep of PETIC’s quality management system and Q-Pulse.
* Take responsibility for resolving issues independently within PETIC’s GMP operations where they fall within set role objectives.
* Handle, document and test incoming materials and consumables to ensure reagents and consumable stocks are available as needed.
* Investigate and analysis specific issues within PETIC’s radiopharmaceutical production facility, creating recommendation reports, supported by advances within PET and GMP.
* Ensure that the provision of radiopharmaceuticals is delivered to PETIC and its customers, proactively changing the delivery according to customer requirements.
* Establish working relationships with key contacts, developing appropriate communication links with the University’s Schools/Directorates and outside bodies as required.
* Create specific working groups from colleagues across the University to achieve PETIC’s objectives
* Plan and deliver specific small-scale projects, co-ordinating and supervising project teams created as needed.
* Develop, deliver, and monitor training and operator validation within PETIC.
* Undertake a variety of administrative duties to support the department.
* Instruct and guide other employees across the University within PETIC.
General Duties
* To deputise for the Head of Radiopharmacy when required.
* Ensure that an understanding of the importance of confidentiality is applied when undertaking all duties
* Abide by University policies on Health and Safety and Equality and Diversity
* Perform other duties occasionally which are not included above, but which will be consistent with the role
* Act as Radiation Protection Supervisor and maintain a surveillance of all aspects related to radiation safety of staff working in the Cyclotron Production Facility and advise all staff on safe working practices. Ensure all staff comply with the requirements of the Radiation Local Rules and Health and Safety at Work Order.
* Participate in the day-to-day operation of the GMP Production Facility.
Person Specification
Essential Criteria
Qualifications and Education
* Degree a in scientific discipline /NVQ 4 or equivalent Professional membership/experience
Knowledge, Skills and Experience
* Substantial experience of working within an aseptic pharmaceutical production facility
* Able to demonstrate professional knowledge within GMP to give advice and guidance to internal and external customers
* Experience in developing new processes and procedures
Customer Service, Communication and Team Working
* Ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people
* Evidence of ability to explore customers’ needs and adapt the service accordingly to ensure a quality service is delivered
* Proven ability to develop networks in order to contribute to long term developments
Planning, Analysis and Problem solving
* Evidence of ability to solve expansive problems using initiative and creativity; identify and propose both practical and innovative solutions
* Evidence of demonstrable knowledge of key advances within the field of Radiopharmaceutical production
* Evidence of ability to undertake and deliver specific projects and supervise short term project teams
Desirable Criteria
* Postgraduate/Professional qualification
* Previous experience in Nuclear Medicine or Radiopharmacy
* Experience as a Radiation Protection Supervisor
* Prior relevant knowledge and experience related to distribution of medicinal products
* Fluency in Welsh, written and oral
Additional Information
* Assist the Head of Radiopharmacy Production to ensure the duties of Production Manager as defined in Eudralex Annex 4 Chapter 2 are carried out to
* Ensure compliance with Eudralex Volume 4 - The Rules Governing Medicinal Products in the European Union or subsequent equivalent legislation
* Ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
* Approve the instructions relating to production operations and to ensure their strict implementation.
* Ensure that the production records are evaluated and signed by an authorised person.
* Ensure the qualification and maintenance of his department, premises and equipment.
* Ensure that the appropriate validations are done.
* Ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
* The authorisation of written procedures and other documents, including amendments.
* The monitoring and control of the manufacturing environment.
* Plant hygiene.
* Process validation
* Training of GMP staff
* The approval and monitoring of suppliers of materials.
* The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities.
* The designation and monitoring of storage conditions for materials and products.
* The retention of records.
* The monitoring of compliance with the requirements of Good Manufacturing Practice.
* The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
* Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
* Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Detailed Duties Relating to Good Distribution Practice
* Assist the Head of Radiopharmacy Production in ensuring that the provisions of the licence are observed. Ensure that the delivery operations do not compromise the quality of medicines
* Maintain an adequate quality system is established and oversee delivery of medical products
* Oversee audit of the quality system and to carry out independent audits
* Ensure that adequate records are maintained
* Ensure that all personnel are trained Ensure full and prompt cooperation with product licence holders in the event of recalls.
* Employ due diligence in the discharge of their duties, maintaining full compliance to procedures and appropriate regulations.
* Report to senior management, the licence holder and the MHRA, any suspicious event which they become aware of.
Salary Range Min.
40,247
Salary Range Max.
45,163
Job Category
Technical
Grade
Grade 6 #J-18808-Ljbffr