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
1. Contributing technical knowledge and participating in the preparation and review of documentation for the build, installation, and commissioning of the PET Radiopharmacy
2. Validation of equipment, production and QC processes according to approved protocols
3. Drafting and maintaining COSH and radiation risk assessments
4. Manufacture PET radiopharmaceuticals using hot cell and isolators
5. Sanitisation/cleaning aseptic suite facilities
6. Aseptic dispensing of PET radiopharmaceuticals using negative pressure isolator technology
7. Adopting radiation protection technique at all times ALARA
8. Packing and dispatch of radiopharmaceuticals according to local guidelines and transport regulations
9. Collating received orders and inputting them into the dispensing database
10. To carry out staff training and knowledge sharing when applicable
11. Manufacture PET radiopharmaceuticals using hot cells/isolators
12. Sanitisation/cleaning aseptic suite facilities
13. Aseptic dispensing of PET radiopharmaceuticals using negative pressure isolator technology
14. Adopting radiation protection technique at all times ALARA
15. Packing and dispatch of radiopharmaceuticals according to local guidelines and transport regulations
16. Collating received orders and inputting them into the dispensing database
17. Sanitation and transferring of consumables in the aseptic suite and isolators
18. Cleaning the isolators and Radiopharmacy facility according to SOP’s
19. Aseptic Suite monitoring including Environmental monitoring, Radiations monitoring
20. First line maintenance of equipment
21. Carry out Quality Control procedures analysing the radionuclide and radiochemical purity of radiopharmaceuticals using standard analysis packages as specified in the European Pharmacopoeia
22. Undertake laboratory cleaning, maintenance and procedures required for GMP analysis of radiopharmaceuticals
23. Recording of the logs for fridge, freezers, isolator checks and all other logs
24. Raising and completing deviation reports where applicable
25. Participate in Root Cause Analysis and CAPA identification
26. Effective communication with all colleagues to facilitate efficiency in both production and quality related matters
27. Maintain paper and electronic records from all production processes for statutory purposes, including production and quality control under GMP
28. Participate in qualification/requalification exercise as required including preparing documentation and execution of protocols
29. Setting up production orders in the system
30. Checking stock level and ordering products
31. Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues
32. Comply with the requirements of the Pharmaceutical Good Manufacturing Practice (GMP), Ionising Radiation Local Rules, COSSH and Health & Safety procedure
33. Training of Technicians in PET manufacturing and QC processes, and standard operating procedures across the site
Competencies:
34. GMP guidelines and quality policy
35. Quality systems
36. Ionising Radiation Regulations
37. COSHH and Health & Safety procedure
38. Accuracy
39. Dedication/commitment
40. Quality and compliance commitment
41. Orderliness, tidiness and an eye for safety at the workplace
42. Self-reliance and self-inspection ability
43. Communication and Team Working
44. Working efficiently
45. Planning, Analysis and Problem-solving ability
Requirements
Level of professional and intellectual ability
46. Knowledge of Ionising Radiation Local Rules, COSSH and Health & Safety procedure (Desirable)
47. Knowledge of working within a GMP environment
48. Willingness to work flexibly on a rotating 12-hour shift pattern between 00:00 (midnight) to 17:00
49. Validation experience (Desirable)
Education/experience
50. Related Science Degree
51. Aseptic dispensing experience or Radiopharmacy experience
52. 3–5 years professional experience
53. Working knowledge of pharmaceutical chemistry and good manufacturing practice is required
Skills
54. Excellent team player but also be
55. Able to work on own initiative
56. Good customer relation skills
57. Communication skills
58. Practical ability
59. Excellent timekeeping competences
60. Stress handling
61. Excellent attention to detail
62. High level of computer literacy