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Redefining the experience of cancer through our trusted legacy in nuclear medicine
At Curium, we have a singular focus – to develop, manufacture and supply world-class radiopharmaceutical products around the globe. We strive to innovate further in nuclear diagnostics and therapies so we can enhance the lives of people with cancer.
Every day we see the impact that our treatments offer and the potential they have to provide a world beyond cancer and other debilitating conditions. We continue to push boundaries and reach new heights in everything we do, supported by significant investment into new technologies and therapies.
Summary of Position
To preform 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 Environmental Monitoring process and ensure data are recorded and trended in the QMS
* Reading Microbiological plates, bioburden and sterility samples
* Interpretation and recording of Microbiological data and report any out of specifications 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 lab equipment
* Partake in validation activities, and 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/specials guidelines and EP/USP
* Ensure timely completion and update of all Quality records and trackers
* Raising and completing deviation reports, OOS, 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 & Safety procedure
Requirements
Requirements
* Level of professional and intellectual ability
* Knowledge of Ionising Radiation Local Rules, COSSH and Health & Safety procedure (desirable)
* Knowledge of working within a GMP environment
* A willingness to work flexibly and commit to early working hours in shift pattern.
Education/experience
* Related Science Degree i.e. analytical science, chemistry or related discipline
* Working knowledge of pharmaceutical chemistry and good manufacturing practice is desirable
* Experience in using QC equipment: GC, TLC, HPLC, pH meter would be advantageous
Skills
* Excellent team player
* Able to work on own initiative
* Practical ability
* Stress handling
* Excellent attention to detail
* Full Driving licence (required)
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is anequal opportunity employerand believes everyone deserves respect, dignity and equality. All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Job Segment: QC, Microbiology, Pharmaceutical, Medical Technologist, Nuclear, Quality, Science, Healthcare, Energy
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