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Quality Assurance and Regulatory Affairs Specialist - ANZ
- Global innovator of Pharmaceutical Products
- Join a fast growing tier one company
About Our Client
Our Client is a leading global innovator of Pharmaceutical products that improve patient lives. Their mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive products and procedures.
Reporting to the Quality Assurance and Regulatory Affairs Manager, the successful candidate will be responsible for the execution and administration of QA programs, policies, processes and procedures. You will need to provide expertise and guidance to the business in interpreting and executing against the quality system elements to ensure compliance. With responsibility for the preparation of product submissions to the TGA you will be exposed to products across all areas of Pharmaceutical and have the opportunity to liaise with local and overseas suppliers and manufacturers to ensure all documentation is in place for new applications and existing licences. Additionally:
- Execute the Quality Management Review process, including the collection and reporting of key performance indicators for monitoring the health of the quality system
- Taking a lead role in the implementation of continuous improvement activities and execution of the internal quality audit program
- Assess regulatory requirements for new products and develop strategies for achieving regulatory approvals in a timely manner
- Perform all activities required to obtain and maintain awareness of the regulatory environment within Australia and New Zealand
The Successful Applicant
You will ideally possess a Bachelor's degree in a technical or scientific field and be experienced in quality assurance and regulatory affairs. Comprehensive knowledge of TGA and auditing quality management systems is highly desirable, as is a working knowledge of the Australian Medical Device regulations. Experience with leading process improvement projects will also be a distinct advantage.
What's on Offer
Your commitment and passion to drive projects will be rewarded with a highly attractive salary as well as ongoing career development. As a member of the ANZ team, you'll be part of an inclusive, dynamic culture, working with a company whose focus is patient care.