Radiopharmacy Technician

Summary of Position

To participate in the production of PET radiotracers for clinical use. It involves production and dispensing and quality control of radiopharmaceuticals, operating a range of automated and manual radiochemical synthesis and quality control equipment. It Also involves assisting in all aspects of operating and maintain the facility to GMP standards, including equipment and laboratory maintenance, environmental monitoring, incoming materials management, and stock control. 

Essential Functions

• Prepare PET Radiopharmaceuticals

  • Manufacture PET radiopharmaceuticals using hot cell and isolators.
  • Sanitisation/cleaning aseptic suite facilities.
  • Aseptic dispensing of PET radiopharmaceuticals. Using negative pressure isolator technology.
  • Adopting radiation protection technique at all times ALARA
  • Packing and dispatch of radiopharmaceuticals according to local guidelines and transport regulations.
  • Collating received orders and inputting them into the dispensing database.
  • To carry out staff training and knowledge sharing when applicable.

• Participation in maintaining clean room and lab
  • Sanitation and transferring of consumables in the aseptic suite and isolators.
  • Cleaning the isolators and Radiopharmacy facility according to SOP’s.
  • Aseptic Suite monitoring including Environmental monitoring, Radiations monitoring.
  • Undertake laboratory cleaning and maintenance and procedures as required.
  • Examples of duties include:
    monitoring and upkeep of PET radiochemistry modules and environment
    assisting with the routine monitoring of facility and equipment
    assisting with routine servicing and maintenance of equipment
    testing and maintenance of user serviceable parts
    receipting goods, checking materials and performing the stock control of consumables
    disposal of waste chemicals and materials.
  • Recording of the logs for fridge, freezers, isolator checks and all other logs.

• Quality Assurance Compliance 
  • Raising and completing deviation reports where applicable.
  • Participate in Root Cause Analysis and CAPA identification.
  • Effective communication with all colleagues to facilitate efficiency in both production and quality related matters.
  • Maintain paper and electronic records from all production processes for statutory purposes, including production and quality control under GMP.

• Set up production orders
  • Setting up production orders in the system.
  • Checking stock level and ordering products.

• Corporate guidelines and General Duties
  • Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues.
  • Comply with the requirements of the Pharmaceutical Good Manufacturing Practice (GMP), Ionising Radiation Local Rules, COSHH and Health & Safety procedure.

Requirements

Professional knowledge and working requirements

• Understanding of GMP procedures.
• Awareness of Ionising Radiation Local Rules and radiation protection principles (ALARA).
• Working knowledge of sterile pharmaceutical GMP principles, including batch record completion, deviation reporting, and data integrity (ALCOA+).
• COSHH and Health & Safety awareness relevant to a chemical and radioactive materials environment.
• Willingness to work flexibly on a rotating 8-hour shift pattern, which includes a night shift (midnight to 08:00) and a day shift (flexible start, 8 hours), scheduled according to the site rota and business need.

Education/experience

• A degree in a relevant science discipline (Pharmacy, Pharmaceutical Science, Chemistry, Analytical Chemistry, Biomedical Science, or Chemical/Biomedical Engineering).
• Equivalent qualifications or a strong record of relevant industry experience will be considered.
• Cleanroom experience (aseptic manufacturing, RadioPharmacy).
• Knowledge of routine maintenance and basic troubleshooting of analytical equipment including HPLC and GC systems (Desirable).
• Experience with maintenance and upkeep of production equipment (e.g. dose calibrators, pH meters, synthesis modules) (Desirable).
• Awareness of Validation processes (IQ/OQ/PQ) and Change Control procedures within a GMP environment (Desirable).