Quality Assurance Manager
7 hours ago
Fuse Recruitment is seeking a highly skilled Quality Assurance Manager to join our client's team in Brisbane. As a key member of the Quality team, you will play a crucial role in the overall management of the Quality Management System (QMS).
About the RoleAs the Quality Assurance Manager, you will be responsible for leading all quality assurance initiatives supporting the manufacture of radiopharmaceutical APIs. This includes designing, monitoring, implementing, maintaining, and updating the QMS to ensure regulations are adhered to and industry best practices are referenced.
Key Responsibilities- Lead all quality assurance initiatives supporting the manufacture of radiopharmaceutical APIs.
- Design, monitor, effectively implement, maintain, and update the Quality Management System (QMS) to ensure regulations are adhered to and industry best practices are referenced.
- Oversee audit schedules and the execution of audit plans, reviews, and audit reports.
- Track corrective/preventive actions associated with vendors in accordance with applicable regulations, guidelines, and SOPs.
- Work closely with Production, Regulatory Affairs, and other departments within the organisation to ensure compliance with QA/RA requirements, including FDA, TGA, EMA, and other relevant regulatory agencies throughout the product lifecycle.
- A tertiary qualification in Radiopharmaceuticals, Nuclear Medicine, or equivalent.
- Demonstrated experience designing, implementing, and monitoring a Quality Management System to meet the requirements of PIC/S, TGA, FDA, GMP, and/or EMA.
- Experience working with short shelf-life products (i.e., 24 hours or less) or an understanding of the manufacturing and supply chain processes involved to achieve quality products in a short timeframe.
- Excellent written and verbal communication skills with previous experience in technical writing for SOPs, manuals, and other quality documentation.
- A proactive and adaptable approach to evolving product requirements.
Fuse Recruitment is a specialist recruitment agency for the scientific and manufacturing industry. We actively source a variety of roles for a broad range of organisations. If you are looking for a new opportunity, we'd love to hear from you.
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