We have a new opportunity for a Production Manager to join our Radiopharmacy team.
This is a full-time position working 40 hours a week. Our site's operational hours are 24/6 with operational hours 00:00 to 20:00, so shift work is required.
You should be a scientific graduate with a scientific background, ideally with experience of (radio) pharmaceutical manufacture in a GMP environment.
To be successful in this role, you will demonstrate
* excellent verbal and written communication skills, analytical skills, a logical approach to problem-solving, and good attention to detail. As an effective team member, you will have great organizational skills with the ability to work under pressure.
* Be educated to a degree level in a related scientific discipline or able to demonstrate relevant experience.
* Ideally, be able to demonstrate experience in Radiochemistry or related disciplines.
* Ideally, be able to demonstrate knowledge of GMP, validation, and relevant regulations.
* Validation experience (including laboratory equipment and process validation) would be advantageous.
* Previous experience of operating in a GMP grade C cleanroom, operation of a GMP grade A isolator, and/or distribution of radiopharmaceuticals would be advantageous.
Please note that we will be interviewing throughout the duration of this advert. Therefore, if you are interested in this role, an early application is advised as we may close the advert prior to the advertised date.
Production
Daily, routine production of PET radiopharmaceuticals, including 18F-FDG, for Alliance Medical Radiopharmacy in strict adherence to GMP and relevant EU pharmacopoeia standards.
Operate routine protocols for customer orders and distribution of 18FDG and other PET and tracers to scanning sites.
Maintenance and upkeep of production equipment and associated plant, including first-line scheduled and emergency maintenance, in collaboration with Alliance Medical Radiopharmacy engineers.
Ensure efficient performance of, and undertake first-line maintenance and any required troubleshooting of the FDG Synthesizers, Dispensing Equipment, Hot Cells, including dose calibration, monitoring, and sterility checks within the context of strict application of environmental and ‘clean room’ protocols.
Faults and issues will be addressed promptly, with records maintained for any dysfunction – operational, equipment, or environment integrity. Interpret and rectify operational faults where possible, and liaise with engineers and suppliers as necessary.
Quality Systems
Operating to approved quality standards by recording Production quality-related actions (e.g., deviations and change controls) in a timely manner, to comply with AMR policies and regulatory requirements.
As a Principal Operator, act as production radiochemist for radio-synthesis of PET tracers in accordance with a pre-determined daily timetable, which will include some night work on a rotational shift rota.
Chemical Preparation and management, including monitoring and maintaining lab stocks of chemicals, consumables, and spare parts, as well as the safe disposal of waste chemicals and materials.
Standard Operating Procedures will be prepared and reviewed in accordance with relevant guidelines for approval by the QP and adoption by the unit.
Training will be provided to others selected as rota/backup in production of Radiopharmaceuticals.
Safety and Control measures will be strictly adhered to, assuming responsibility for the safe and efficient handling of all radioactive substances (solid, gas, liquid) received from the Centre’s cyclotron, including their synthesis, transmission, dispensing, storage, containerization, packing, despatch, transport, decay control, and release.
Regulatory compliance is essential, with strict adherence to GMP, GLP, and safety protocols laid down by the MHRA, EA, and HSE in accordance with issued licenses as determined from time to time.
About Alliance Medical
Alliance Medical are Europe’s leading independent provider of imaging services, combining service excellence and innovative imaging technologies to improve patient care and support NHS and independent organizations with their ongoing imaging requirements.
We live by our company values to ensure the highest level of patient care:
* Collaboration: We work together and in partnership for all our patients, respecting expertise and combining it to achieve more.
* Excellence: We never compromise, striving to deliver the very best in everything we do to ensure the highest quality of care, treating our patients and each other with compassion, dignity, and respect.
* Learning: Knowledge and understanding come from learning, and at Alliance Medical, we are committed to ensuring each and every one of us keeps on learning and continuously looks for improved ways of working.
* Efficiency: Efficiency in healthcare means more patients get better care. We constantly seek new ways to use the scarce resource of healthcare more intelligently so that more people can live longer, fuller lives.
* Openness: We act with transparency and honesty in everything we do, where staff are encouraged to speak up to ensure a safe and secure environment for our patients.
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