About the Company/Role: Based in Brisbane, our client is establishing itself as a future leader in manufacturing radiopharmaceutical APIs and devices and delivering world-class research and expertise to develop novel therapies to significantly improve survival and quality of life for patients with cancer.
This is an opportunity to join a growing organisation and be part of the journey, from product development through to clinical trials and manufacturing, whilst establishing GMP, TGA, FDA compliance.
As a Senior QA Associate you will be involved in supporting the implementation, update, maintenance of the Quality Management System to meet cGMP, industry standards and applicable guidelines.
Key Responsibilities:- Oversee and execute QA processes, including batch record reviews, deviation investigations and CAPA implementation.
- Participate in internal and external audits, including preparation, facilitation and follow up on findings.
- Contribute to quality risk management activities and facilitate root cause analyses for quality issues.
- Prepare and analysis complex data, as well as identify trends and patterns in the data in relation to quality management requirements.
- Complete and maintain accurate production records and documentation, including inventory levels, batch records and associated reports, in accordance with applicable guidelines such as cGMP requirements.
Skills/Experience:- Tertiary qualification in life sciences, chemistry, biology or closely related discipline
- Extensive experience in quality assurance preferable in the radiopharmaceutical industry or sterile manufacturing environments.
- Analytical technical knowledge and experience.
- Experience of sterile manufacturing.
- knowledge and understanding of cGMP regulations, TGA and FDA guidelines, and radiation safety regulations applicable to radiopharmaceutical manufacturing.
Apply! If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed). Or, if you have any questions, please contact the Simon on 07 3175 0680 or brisbane@evolvescientific.com.au With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.