Summary of Position To perform quality control analysis on radiopharmaceuticals for patient use and raw material testing in accordance with principles of Good Manufacturing Practice (GMP).
Essential Functions Accurately perform Quality Control testing on all manufactured products on site according to MA, GMP and EP guidelines; use of gas chromatography (GC), TLC and HPLC Manage the Environmental Monitoring process and ensure data is recorded and trended in the QMS Reading Microbiological plates, bioburden and sterility samples Interpretation and recording of Microbiological data and report any out-of-specification, ensuring appropriate action is taken in a timely manner Review and maintain QC logbooks and data to ensure the site meets all its objectives in relation to data integrity policy Perform and manage maintenance and calibration of lab equipment Partake in validation activities, preparation and execution of protocols Liaise with Quality Management on validation strategy and training Checking stock level and ordering supplies Endotoxin testing Raw materials testing Goods in check/inspection as part of quality inspections of incoming materials Reviewing compliance of analytical methods with GMP/special guidelines and EP/USP Ensure timely completion and update of all Quality records and trackers Raising and completing deviation reports, OOS, and change controls 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 QC processes for statutory purposes, including quality control under GMP Comply with the requirements of the Pharmaceutical Good Manufacturing Practice (GMP), Ionising Radiation Local Rules, COSSH and Health