As the Quality Assurance Manager you will play a key role in the overall management of the QMS. Join a small team who collaborate together to enhance the performance of the QMS whilst working dynamically in a consistently growing organisation. This position is based in the Western Suburbs of Brisbane with relocation support for interstate candidates on offer if required.Who will you be working with?Our Client is a clinical stage radiopharmaceutical company developing treatments to significantly improve survival and quality of life for patients with cancer. As they continue to make advancements in their product development and clinical phases, they are constantly improving their Quality Management Systems. The Quality team are a small team who take a lot of pride in providing their expertise to the wider business, supporting the development of products, introduction of GMP manufacturing systems and progression of clinical trials.What are the benefits?
- Lead role - opportunity for your next step
- Competitive salary package + relocation support (if required)
- Career growth on offer
- Culture of teamwork towards common goals
- Lead all quality 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, Life Sciences 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.
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