Radiopharmaceutical Quality Assurance Specialist
7 days ago
At Fuse Recruitment, we specialize in the scientific and manufacturing industry, and we are currently looking for a highly skilled Radiopharmaceutical Quality Assurance Specialist to join our team.
The successful candidate will have experience in quality management, preferably in the radiopharmaceutical industry. They will be responsible for overseeing the overall administration of quality assurance in all manufacturing aspects of 212Pb-based API and radiopharmaceutical products.
This role involves the effective implementation and maintenance of the Quality Management System (QMS), ensuring efficient use of resources, implementing high standards of quality and safety while maintaining compliance with regulatory requirements and industry standards.
Key responsibilities include:
- Design, monitor, implement, maintain, and update the QMS to ensure regulations are adhered to and industry best practices are referenced.
- Overall responsibility and timely management for batch record review, change control, investigations into deviations, and execution of CAPA.
- Approve or reject starting materials and packaging materials.
- Participate in or initiate the company quality manual.
- Participate in management reviews of process performance, product quality, and of the QMS and advocate for continual improvement/quality by design.
- Determine the standards for the ongoing GMP training of all employees as well as supervision of GMP compliance.
- Review, evaluate, and approve SOPs and other GMP-related documents.
- Responsible for GMP training of functional areas and contribute to the development of appropriate GMP training for internal and external personnel.
The ideal candidate will possess a strong technical knowledge of radiopharmaceutical manufacturing processes, equipment, and quality control principles, as well as in-depth knowledge and understanding of cGMP regulations, TGA, and FDA guidelines, and radiation safety regulations applicable to radiopharmaceutical manufacturing.
In addition, they will have excellent communication skills and strong analytical problem-solving skills, with the ability to collaborate effectively across departments and communicate with stakeholders at all levels.
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