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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 Site open 24/6 with operational hours 00:00 to 20:00 so shift work is required.
Job Responsibility:
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
arrange first-line scheduled and emergency maintenance for production equipment and associated plant
ensure efficient performance of, and undertake first-line maintenance and any required troubleshooting of the FDG Synthesisers, Dispensing Equipment, Hot Cells, including dose calibration, monitoring and sterility checks
maintain records of faults on any dysfunction
operating to approved quality standards by recording Production quality related actions
on a rota basis, act as production radiochemist for radio-synthesis of PET tracers
monitoring and maintaining lab stocks of chemicals, consumables, and spare parts as well as the safe disposal of waste chemicals and materials
prepare and review SOPs
provide training and support for others
assume responsibility for the safe and efficient handling of all radioactive substances
responsible for following agreed safety procedures
strictly adhere to GMP, GLP and safety protocols laid down by the MHRA, EA and HSE
Requirements:
Scientific graduate with a scientific background
ideally with experience of (radio) pharmaceutical manufacture in a GMP environment
excellent verbal and written communication skills
analytical skills
a logical approach to problem solving
good attention to detail
great organisational skills
ability to work under pressure
educated to a degree level in a related scientific discipline or able to demonstrate relevant experience
Nice to have:
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
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