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-related quality assurance 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.
Location: 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. Following project plan and associated SOP’s as they are created to implement and build the QMS and systems
4. Reviewing compliance of production and analytical methods with GMP/specials guidelines and EP, BP and/or SmPC
5. Documentation management including review and update SOPs and forms
6. Assist with deviations, incidents and investigations, OOS, CAPA, Change control and release of incoming materials
7. Review QC tests and Micro results, managing Out of specification results
8. Ensure timely completion and update of all Quality records and trackers
9. Support the site to ensure it is GMP compliant by making sure SOPs are up to date
10. Assist with elements of the QMS including Deviations, Complaints, OOS, CAPA, Change Control, Recall, Micro Out of Specification, Risk Assessments and related trending
11. Following GLP
12. Adherence to SOP’s
13. Aseptic Suite monitoring including Environmental monitoring, Radiations monitoring
14. Carry out Quality Control procedures analysing the radionuclide and radiochemical purity of radiopharmaceuticals using standard analysis packages as specified in the European Pharmacopoeia
15. Undertake laboratory cleaning, maintenance and procedures required for GMP analysis of radiopharmaceuticals
16. 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
17. Recording of the logs for fridge, freezers, isolator checks and all other logs
18. Raising and completing deviation reports where applicable
19. Participate in Root Cause Analysis and CAPA identification
20. Effective communication with all colleagues to facilitate efficiency in both production and quality related matters
21. Maintain paper and electronic records from all production processes for statutory purposes, including production and quality control under GMP
22. Participate in qualification/requalification exercise as required including preparing documentation and execution of protocols
23. Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues
24. Training of staff following all associated procedures and guidelines
Competencies
25. GMP guidelines and quality policy
26. Regulations
27. Quality systems
28. Accuracy
29. Dedication/commitment
30. Quality and compliance commitment
31. Orderliness, tidiness and an eye for safety at the workplace
32. Self-reliance
33. Working together
34. Working efficiently
Requirements
Level of professional and intellectual ability
35. Knowledge of radiation (Desirable)
36. Shift work required
Education/experience
37. Related Science Degree
38. 2–3 Years Radiopharmacy Experience
39. Aseptic dispensing experience or Radiopharmacy experience or working with isolators is desirable
40. Working knowledge of pharmaceutical chemistry and good manufacturing practice is required
Skills
41. Excellent team player
42. Basic computer skills
43. Good customer relation skills
44. Communication skills
45. Practical ability
46. Excellent timekeeping competences
47. Stress handling
48. Excellent attention to detail
Competencies