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    -    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
Quality Control and Quality Assurance Compliance     -    Carry out Quality Control procedures analysing the radionuclide and radiochemical purity of radiopharmaceuticals using standard analysis packages as specified in the European Pharmacopoeia.
-    Undertake laboratory cleaning, maintenance and procedures required for GMP analysis of radiopharmaceuticals
-    Examples of duties include: preparation of chemicals including HPLC solvents for routine use; monitoring and upkeep of PET radiochemistry modules and environment; assisting with the routine monitoring of facility and equipment, supervising routine servicing of equipment, testing and maintenance of user serviceable parts; receipting goods, checking materials and performing the stock control of laboratory consumables, chemicals and gases and disposal of waste chemicals and materials.
-    Recording of the logs for fridge, freezers, isolator checks and all other logs
-    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.
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, COSSH and Health & Safety procedure
 

Requirements

Availability to work from TUESDAY TO SATURDAY on shifts

Level of professional and intellectual ability
-    Knowledge of Ionising Radiation Local Rules, COSSH and Health & Safety procedure (Desirable)
-    Knowledge of working within a GMP environment.
-    A willingness to work flexibly and commit to early working hours in shift pattern. 
Education/experience
-    Related Science Degree 
-    Aseptic dispensing experience or Radiopharmacy experience or working with isolators is desirable
Knowledge
-    working knowledge of pharmaceutical chemistry and good manufacturing practice is required
Skills
-    Excellent team player but also be
-    Able to work on own initiative
-    Good customer relation skills
-    Communication skills
-    Practical ability
-    Excellent timekeeping competences
-    Stress handling
-    Excellent attention to detail