Senior Radiopharmacy Technician Newcastle

Job description:

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.

The position is located in Newcastle.

Essential Functions

• Contributing technical knowledge and participating in the preparation and review of documentation for the build, installation, and commissioning of the PET Radiopharmacy
• Validation of equipment, production and QC processes according to approved protocols
• Drafting and maintaining COSH and radiation risk assessments
• 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
• Manufacture PET radiopharmaceuticals using hot cells/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
• 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
• 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
• 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
• Setting up production orders in the system
• Checking stock level and ordering products
• 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
• Training of Technicians in PET manufacturing and QC processes, and standard operating procedures across the site

Competencies:

• GMP guidelines and quality policy
• Quality systems
• Ionising Radiation Regulations
• COSHH and Health & Safety procedure
• Accuracy
• Dedication/commitment
• Quality and compliance commitment
• Orderliness, tidiness and an eye for safety at the workplace
• Self-reliance and self-inspection ability
• Communication and Team Working
• Working efficiently
• Planning, Analysis and Problem-solving ability

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
• Validation experience (Desirable)

Education/experience

• Related Science Degree
• Aseptic dispensing experience or Radiopharmacy experience
• 3–5 years professional experience
• 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