Senior Radiopharmacy Technician Oxford

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

Essential Functions

1. Project Phase:
2. Participate 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.
3. Draft and maintain COSH and radiation risk assessments.
4. Prepare PET Radiopharmaceuticals:
5. Manufacture PET radiopharmaceuticals using hot cells and isolators.
6. Sanitisation and cleaning of aseptic suite facilities.
7. Aseptic dispensing of PET radiopharmaceuticals using negative pressure isolator technology.
8. Preparation of Radiopharmaceuticals:
9. Manufacture PET radiopharmaceuticals using hot cells/isolators.
10. Sanitisation and cleaning of aseptic suite facilities.
11. Aseptic dispensing of SPECT radiopharmaceuticals using negative pressure isolator technology.
12. Perform GFR processing with senior technicians and production manager.
13. Participation in maintaining clean room:
14. Sanitation and transfer of consumables in the aseptic suite and isolators.
15. Cleaning of isolators and Radiopharmacy facility according to SOPs.
16. Monitoring of the aseptic suite, including environmental and radiation monitoring.
17. First-line maintenance of equipment.
18. Quality Control and Assurance Compliance:
19. Carry out QC procedures analyzing radionuclide and radiochemical purity using standard analysis packages as per European Pharmacopoeia.
20. Maintain laboratory cleaning, maintenance, and procedures for GMP analysis of radiopharmaceuticals.
21. Manage chemicals, monitor PET radiochemistry modules and environment, oversee routine monitoring and servicing of equipment, check materials, manage stock of laboratory consumables, chemicals, gases, and dispose of waste chemicals.
22. Record logs for fridge, freezers, isolator checks, and all other logs.
23. Raise and complete deviation reports as needed.
24. Participate in root cause analysis and CAPA processes.
25. Communicate effectively with colleagues to ensure efficiency in production and quality matters.
26. Maintain records of production and QC processes for statutory purposes under GMP.
27. Participate in qualification/requalification exercises, including documentation and protocol execution.
28. General:
29. Adopt radiation protection techniques at all times, following ALARA principles.
30. Handle packing, dispatching, and inputting orders into the dispensing database.
31. Set up production orders, check stock levels, and order products as needed.
32. Adhere to legal and organizational procedures regarding quality, safety, health, and environmental issues, including GMP, Ionising Radiation Rules, COSSH, and safety procedures.
33. Train and share knowledge in PET manufacturing, QC processes, and SOPs across the team.

Requirements

• Valid independent work permit.
• Knowledge of Ionising Radiation Rules, COSSH, and safety procedures (desirable).
• Experience working within a GMP environment.
• Willingness to work a rotating 12-hour shift pattern between 00:00 and 17:00 after project initiation.
• Validation experience (desirable).
• Related Science Degree.
• Aseptic dispensing or radiopharmacy experience, 3-5 years of professional experience.
• Knowledge of pharmaceutical chemistry and GMP.
• Skills include teamwork, initiative, customer relations, communication, practical ability, time management, stress handling, attention to detail, and high computer literacy.

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