澳洲大型药厂招聘QA Manager

Our company is a successful Australian manufacturer with multiple businesses awards. We specialise in manufacturing Health Supplements (complementary medicines and supplementary food) and Skin Care products.

For the Role
1. In charge of all QA/QC/Regulatory Affair operations such as:
• Inspection of all incoming materials
• Release for supply of all finished products
• Creating and maintaining master files for all raw materials
2. Ensure QA system compliance with TGA regulations and Audits, including but not limited to:
• Create and maintain all related Documentation, Batch Records, CAPA, SOPs updates and Site Master File and formulations and specifications and all GMP and technical documents.
• Responsible for internal and external GMP audits
• Train all relevant personnel on latest cGMPs and PIC/S guidelines
• Equipment and process validations
3. Perform and coordinate and maintain stability program
4. Liaise with suppliers and customers and external laboratories on technical issues including formulations, quality, stability and etc.
5. Research and develop new formulations and specification as required
6. Supervise and manage QA / QC / R&D Team and provide constant training to the team
7. Coordinate / perform / assist with product registration process include research therapeutic functions of new products and prepare and submit ARTG listing application
8. Assist with preparing text for products brochures and labels.
9. Maintain existing Licenses (e.g. TGa, HACCP) and acquire required licenses/certificate (e.g. organic processing license; AQIS license for dairy or infant formula products and etc.)
10. Ensure that all production staffs are fully trained as per PIC/S and GMP Quality Management system.
11. Support other departments on technical and quality issues especially Sales / Production / Operations departments.
12. Any other tasks and functions of QA/QC/ Regulatory Affairs/R&D

Selection Criteria
1. At least 3 years’ experience in QA in pharmaceutical companies, coupled with tertiary degree in QA / Pharmacy / Science.
2. Able to work with minimal oversight, but highly motivated to achieve high results
3. Excellent communication skills and computer literate (preferably SAP)
4. Strong Leadership skill and management experience
5. Ability to become part of the Team and customer oriented
6. Have Can-Do attitude and creative thinking and problem solving approach
7. Understand and apply pragmatic thinking and hands-on approach to deliver results within budget and tight deadlines.