Senior Quality Assurance Specialist
Dublin, Ireland, A94 E4X7
About Curium
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 ensure Curium compliance with the requirements of Good Manufacturing Practice
- To take ownership, maintain and continuously improve the site Quality Management System (QMS) ensuring alignment with current regulations, guidelines and industry standards along with the site QPs
Essential Functions
Quality Management
- Maintain the QMS for PET radiopharmaceutical production
- Ensure compliance with GMP, HPRA, EPA, and Curium requirements
- Translate regulatory standards into SOPs and controlled documents
Quality Documentation
- Manage deviations, complaints, OOS/OOT, change controls, and CAPAs
- Track KPIs and drive continuous improvement
- Review and approve key quality documents
Projects & Products
- Lead quality input for new products and technologies
- Support change control, tech transfer, and global initiatives
Complaints
- Monitor, investigate, and close complaints promptly
Recall/Withdrawal
- Support product recall and withdrawal processes
Validation
- Oversee validation lifecycle and ensure compliance
- Maintain validated, controlled processes
Product Disposition
- Ensure timely release of 18F products
- Work with production and QC on controls and specifications
Auditing
- Plan and conduct internal, supplier, and regulatory audits
- Manage inspection responses and follow-ups
Computer Systems
- Ensure systems comply with Annex 11 requirements
Training
- Provide and participate in GMP and quality training
Customers
- Communicate supply issues in a timely manner
Pharmacovigilance
- Support compliance with GVP requirements
Requirements
- Third level qualification in a scientific discipline – pharmacy, medicine, physics, chemistry, pharmaceutical chemistry and biology
- Minimum 5 years’ QA experience within a licensed environment
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 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.
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