Radiopharmacy Technician Oxford

The post holder will be involved from the early stages of the project which will involve drafting documentation including SOPs and validation protocols for review. Executing validation protocols for the production and quality control of radiopharmaceutical products. Upon completion of the project, the post holder will participate in the GMP production, sterile and aseptic dispensing, and quality control of PET radiotracers for clinical use. Operating a range of automated and manual radiochemical synthesis and quality control equipment. The role also involves assisting in all aspects of operating and maintaining the facility to GMP standards, including documentation, equipment and laboratory maintenance including cleaning, environmental monitoring, incoming materials management, and stock control.

Essential Functions

• Project Phase - Contributing technical knowledge and participating in the preparation and review of documentation for the build, installation, and commissioning of the PET Radiopharmacy.
• Assisting with the validation of equipment, production and QC processes according to approved protocols.
• Drafting and maintaining COSH and radiation risk assessments.
• 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 SOPs.
• Aseptic Suite monitoring including Environmental monitoring, Radiations monitoring.
• First line maintenance of equipment.
• 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.
• Assist in qualification/requalification exercise as required including preparing documentation and execution of protocols.
• Setting up production orders in the system.
• Checking stock level and ordering products.
• Adherence to legal and organizational procedures.