Are you an experienced Quality Manager seeking a 2-3 month temporary assignment?
This is a great opportunity to join a company at a critical juncture, as they transition to a global complementary medicines health company. With innovative projects in the pipeline and a focus on operational excellence, this role offers the chance to step in and support a company that is making a significant impact on a global scale. The role will be located at the company's manufacturing facility in the southeastern suburbs of Melbourne.
You will be responsible for overseeing quality assurance, regulatory affairs and technical compliance for the company's complementary medicine products.
Your key responsibilities will include but not limited to:
- Ensuring each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the marketing authorisation
- Approving or rejecting starting materials, packaging materials, intermediate, bulk and finished products
- Independently performing method and equipment validation, including design and creation and reviewing documentation for compliance as well as process improvements
- Approving specifications, sampling instructions, test methods, and other quality control procedures
- Authorising the release for supply of TGA registered and/or licensed products
- Tracking and maintaining Good Manufacturing Practice (GMP) evidence, ensuring all manufacturing site GMP evidence is current and TGA pre-clearance is sought in a timely manner
In order to be considered for this role, you will have the following qualifications and skills:
- A relevant science or engineering tertiary qualification and demonstrated experience in a TGA regulated environment
- A proven track record of successfully leading third party TGA audits
- Experience leading internal (Quality Compliance, Safety) and External (TGA, FDA) audits
- A minimum 5 years experience in the pharmaceutical, nutraceuticals and/or complementary medicines industries preferably in manufacturing, quality assurance/quality control
- Experience in developing, executing, monitoring, and managing validation activities
How to apply:
Apply with a cover letter outlining your specific qualifications and skills complemented by your CV. We look forward to receiving your application!
