Senior Radiopharmacy Technician Oxford

Summary of Position

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 maintain 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: 
-    Participating in the preparation and review of documentation for the build, installation, and commissioning of the PET Radiopharmacy. Including equipment validation, 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 (negative pressure isolator technology)
Preparation of Radiopharmaceuticals:
-    Manufacture PET radiopharmaceuticals using hot cells/isolators
-    Sanitisation/cleaning aseptic suite facilities
-    Aseptic dispensing of SPECT radiopharmaceuticals (negative pressure isolator technology)
-    Perform GFR processing with the Senior technicians and Production manager
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
-    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.
-    Participate in qualification/requalification exercise as required including preparing documentation and execution of protocols
General:
-    Adopting radiation protection technique at all times ALARA
-    Packing, dispatching, collating and inputting orders into dispensing database per guidelines and regulations
-     Set up production orders; setting up production orders, checking stock levels, and ordering products in the system
-    Corporate guideslines and General Duties; adhering to legal and organisational procedures & guidelines about quality, safety, health, and environmental issues. Complying to GMP, Ionising Radiation Local Rules, COSSH, and Health & Safety Procedures
-    Training; conducting and ssharing knowledge in PET manufacturing and QC processes, and standard operating procedures across

Requirements

Valid independant work permit

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.
-    Willingness to work flexibly on a rotating 12 hour shift pattern between 00:00 (midnight) to 17:00 after the site initiation project is complete.
-    Validation experience (Desirable)
Education/experience:
-    Related Science Degree 
-    Aseptic dispensing experience or Radiopharmacy experience
-    3-5 years professional experience
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
-    High level of computer literacy