Description:
As the Quality Assurance officer you will help to deliver our client's quality products and assist in the management of their TGA GMP standard QMS systems.Who will you be working with?
Our client is an industry leader in the health and wellness space, dedicated to improving consumer health worldwide. Our client leverages their expertise and innovative approach to manufacture a diverse range of functional healthcare products.
This role will work as part of their existing QA team and collaborate closely with their Operations, Packaging and wider teams both locally and in their China based manufacturing plants. You will act as one of their Authorised Persons performing batch release and be part of their QMS systems management and execution.
What are the benefits?
• Opportunity to join an industry leader at the forefront of innovation
• Join a skilled and professional team in a leadership capacity
• Ongoing training and development opportunity
What will you be doing?
- Perform release of bulk and finished products, and components, including issuing CoA and CoC.
- Perform release of batch records to manufacture.
- Draft, review and approve documents including SOPs and specifications.
- Maintain and control ERP codes and BOMs.
- Raise, investigate and document Customer Complaints, Non-Conformances, Deviations, Change Controls, CAPAs related to products / materials and processes.
- Assist in the management and execution of our stability program.
- Assist in the preparation and delivery of annual Product Quality Reports.
- Support the quality and production teams in related tasks, record keeping and documentation
- At least 3 years’ experience working in a regulated GMP environment, including:
- A working knowledge of PICs GMP, TGA GMP guidance documents and standards as they relate to AUST L and OTC medicines, their manufacture, testing, packaging and release.
- Demonstrated experience in performing batch release in a regulated GMP environment.
- Demonstrated experience in quality assurance systems and performing detailed investigations.
- An understanding of product stability and PQR requirements as they relate to complementary medicines.
- An understanding of Validation activities desirable.
- Strong written and verbal communication skills, with a demonstrated ability to engage with cross functional teams.
- High attention to detail and ability to meet tight deadlines.
- A Degree or Diploma in Science, or a related field, desirable.
- Experience with ERP systems.
- A positive / “Can Do” attitude and mindset to be part of a dynamic and diverse work environment.
Apply Now , OR with any specific questions, please contact Christelle Capini at ccapini@fuserecruitment.com.
At Fuse, we specialise in recruitment for the scientific and manufacturing industry, and 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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26 Mar 2025;
from:
uworkin.com