AddressBaxter Laboratories is a TGA licensed manufacturer that offers complete supply services for skin care, sunscreen and topical pharmaceutical products, including; Research and Development, Regulatory Services, Manufacturing, Filling, Warehousing and Global Distribution. Working with best in class and popular brands that are in all major Australian retailers.
The Baxter Laboratories site based in Boronia has experienced year on year growth with expectations for further double figure growth in the future.
Role
Reporting to the Technical Manager, the Quality Assurance Manager position will be lead the Quality function at the facility based in Boronia. You will be responsible for the delivery of a customer centric quality process and strategy that meets the Baxter Laboratories quality standards and maintains all relevant licences.
The Quality Assurance Manager will ensure that proactive processes and training is in place to ensure the site and it's people are living quality as a way of life.
The position comes with a team of direct reports and the ideal candidate will be a driven people leader, who can lead by example technically, as well as nurture an education and development mindset across the team and wider site.
Key responsibilities include;
- Ensure the Quality Management System and Master Quality Schedule is up to date for the requirements for complementary medicines and food products for local and export markets
- Continuously review and improve the QMS process, quality objectives and quality KPI’s
- Lead and support the business to successfully deliver on regulatory and customer audits
- All audits (Internal, GMP etc.) are performed as per MQS.
- Raw material, packaging materials and finished goods are released for manufacture and/or sale as per Orchard and regulatory requirements.
- Assess and audit contract manufacturers
- Manage suppliers for raw materials, packaging materials and services relevant to GMP and quality aspects
- Ensure compliance to GMP and GDP 100% of the time
- Review and verify that all quality documents (e.g., CAPA, Deviation, Change Control etc.) have been correctly completed as per GDP and the site’s requirements.
- Strong working knowledge of TGA requirements
- At least 5 years of experience in a TGA manufacturing environment
- Degree in science or related field
- Experience in managing people
- Ability to problem solve and influence others
- Coaching and supportive work style
- Build strong relationships with key stakeholders including internal leaders as well as external customers
- Experience in improving processes in quality and manufacturing
If you require more information on the role or if you have any further questions, please contact Dean Colwell via email on ****@loop-recruit.com
