Posted on 13th May 2020
About Curium Prague, Czech Republic
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position
To be part of a team manufacturing critical radiopharmaceuticals for patient administration from a newly built and commissioned Radiopharmacy in West London. You will apply the principles of Good Manufacturing Practice to ensure Quality remains at the core of operations.
- Manufacture Pet radiopharmaceuticals using hot cell technology
- Sanitization of hot cells and equipment
- Aseptic dispensing of radiopharmaceuticals using negative pressure isolator technology
- Adopting radiation protection techniques
- Dispatch radiopharmaceuticals according to local guidelines and transport regulations
- Collating received orders and inputting them into the dispensing database
- Stocking consumables in the aseptic suite and isolators
- Monitor isolators and suite for microbial growth to carry out radiation monitoring of the isolators and Radiopharmacy Suite.
- Recording of logs for fridge, freezers, isolator checks etc.
- Filling out exemption deviation reports where applicable
- Communicate effectively with colleagues through either department meetings, one to one’s or quick meets to highlight potential risks or gains to the department
- Comply the legal and organizational procedures & guidelines about quality, safety, health and environmental issues
- Ensure all GMP guidelines and processes are followed
- Support and maintain a positive GMP culture
- Support continuous improvement processes
- Participate internal QA, GMP and 5S audits. Ensuring the site remains compliant with regulations
- Support QC testing on all batches according to SmPC/procedure for batch release
- Review of batch documentation and Quality Control results before batch release
- Ensure EM is done and plates are managed in a time manner
- Support QA activities in accordance with the Quality Management System
- Qualifying the ingress of orders and materials in stock management.
- Equivalent life science degree or professional qualification (Registered Pharmacy Technician)
- Aseptic dispensing experience or Radiopharmacy experience or working with isolators is essential
- Aseptic manufacturing knowledge essential
- Deep knowledge of medical ionising radiation and the regulations supporting the use.
- Thorough understanding of Good Manufacturing Practice (GMP) specifically regarding Manufacturing Special (MS) licenses granted by the MHRA.
- Good pharmacological and radiochemistry knowledge to support the ingress of new radiopharmaceuticals and technologies.
- A working knowledge of cyclotron operations and Flourine-18 radiochemistry.
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 an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
About Curium Prague, Czech Republic
Posted on 25th February 2020