Senior Quality Assurance Specialist

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
• 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.