Radiopharmacy Technician Oxford

Job description:

Summary of Position

The post holder will participate in the Cyclotron operation to generate 18F-Fluoride, GMP production, sterile and aseptic dispensing of PET Radiopharmaceutical tracers. Operating a range of automated and semi-automated radiochemical synthesis, sterile and aseptic dispensing equipment in hot cell isolator technology.

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, inspection and release of incoming materials, and monitoring stock levels. The post holder will operate within a regulated environment and work within a Quality Management System.

Essential Functions

• Cyclotron preparation, start up, irradiation and shutdown. Trending and reporting.
• Manufacture PET radiopharmaceuticals using isolator hot cell technology and automated synthesis units.
• Sanitisation/cleaning aseptic suite facilities.
• Dispensing of PET radiopharmaceuticals using negative pressure isolator technology and automated dispenser units (Aseptic and Sterile)
• Packing and dispatch of radiopharmaceuticals according to local guidelines and transport regulations
• Collating received orders and inputting them into the dispensing database
• Adopting radiation protection technique at all times ALARA
• 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 and Radiation monitoring
• Stock control, inspection and release of incoming materials
• Participate in radioactive and non-radioactive waste management activities
• Gowning and hand washing qualification
• Aseptic Process Qualificatio
• Perform routine environmental monitoring activities according to local procedures and schedule
• Recording and reporting of results
• Report excursions, and assist with investigations and corrective actions
• Checking received orders
• Batch planning
• 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
• Participate in the self-inspection rota
• 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; 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
• 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
• Maintain inspection readiness through GMP-compliant documentation and practices
• Support site regulatory inspections and audits
• Assist with the completion of assigned follow-up action

Requirements

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.
• Aseptic Dispensing Experience (Desirable)

Education/experience

• Related Science Degree or related professional experience
• Aseptic dispensing experience or Radiopharmacy experience (desirable)

Knowledge

• knowledge of pharmaceutical manufacturing and good manufacturing practice is required

Skills

• Excellent team player
• Able to work on own initiative
• Learning and personal development
• Good customer relation skills
• Communication skills
• Practical ability
• Excellent timekeeping competences
• Stress handling
• Excellent attention to detail
• High level of computer literacy