Please enable JavaScript.
Coggle requires JavaScript to display documents.
Tasks, Summary of Tasks - Coggle Diagram
Tasks
Improvement Projects
-
-
-
-
-
-
OOS Procedures
Redesign of OOS Procedure incorporating regulatory requirements and ensuring usability by QC Operators
-
-
-
Day to Day QA Support
Responsible for CAPA system which has seen a transformation from a backlogged and clunky system to more high quality, high impact CAPAs
Support with complex deviations such as failed sterility testing, HEPA filter failures, etc
SOP Updates including comprehensive redesign of critical processes. Implemented easy to use graphic system now utilised by all personnel
Training of key personnel in various aspects of Sterility Assurance, QMS and Production (training includes external parties supporting Curium)
-
QA Improvements
-
Automation
Move to dynamic and automated dashboards for operational, quality and governance
-
-
Training Processes
-
Introduction of controlled system for roll out of training with a view to develop a universal manual for Curium UK radiopharmacies
-
-
-
-
Validations
Analytical Methods
-
SPECT Products including MAG-3, MAA, Nanotop, etc
-
-
-
WDA(H) Support
-
-
Training of WDA(H) personnel in Key GxP areas (Deviation Management, CAPA, Document Control, Change Management, etc
Inspections
GMP
-
-
-
Sit on ispections as SME on Sterility Assurance, QMS metrics, and CAPA system
IMP
Defining procedures that are integrated into the local QMS and ensuring that they are compliant with EU GMP Annex 13 and UK Legislation on Clinical Trials
-
-
-
-