As Quality Systems Administrator, I am responsible to ensure that the Quality System at Metagenics is compliant with regulatory and quality requirements for the manufacture of therapeutic and food products. I ensure that risk management principles are utilised in the process for the assessment, control and review of risks to the quality of the product across it's lifecycle. I managed a team of staff who control the Quality Document Control System for Metagenics.I am also an… Show more As Quality Systems Administrator, I am responsible to ensure that the Quality System at Metagenics is compliant with regulatory and quality requirements for the manufacture of therapeutic and food products. I ensure that risk management principles are utilised in the process for the assessment, control and review of risks to the quality of the product across it's lifecycle. I managed a team of staff who control the Quality Document Control System for Metagenics.I am also an Authorised Person for the Release for Supply of Therapeutic Finished Goods. Show less

As the Quality Assurance Manager, I was responsible for the overall management and leadership for the QA team at Metagenics. • Directly responsible for a diverse range of QA and QC staff• Demonstrated effective communication skills to build relationships with both internal and external clients including TGA, Production, Warehouse, Regulatory Affairs, Research & Development, Marketing, Sales.• Organize QA operations to ensure timely Release for Supply• Involvement with bring New… Show more As the Quality Assurance Manager, I was responsible for the overall management and leadership for the QA team at Metagenics. • Directly responsible for a diverse range of QA and QC staff• Demonstrated effective communication skills to build relationships with both internal and external clients including TGA, Production, Warehouse, Regulatory Affairs, Research & Development, Marketing, Sales.• Organize QA operations to ensure timely Release for Supply• Involvement with bring New Products to market, including New Raw Materials and New Packaging Components.• Ensuring QA operations are compliant to Regulatory Requirements (TGA, PIC/s, GMP, FSANZ)• Participation in 3 successful TGA Inspections.• Establishing and maintaining a compliant Internal Audit program• External Auditing of Contract Manufacturers, Packers and Laboratories• Maintenance and updating of electronic QA Registers (SharePoint, Excel)• Approved Trainer for all QA System processes• Ensuring QA expenditure is within budget (consumables, equipment)• Monthly reporting of compliance issues to Senior Management• Preparation, investigation and analysis of Change Controls, Non Conformances, Planned and Unplanned Deviations, Risk Assessments, Corrective & Preventative Action, Root Cause Analysis and Out of Specifications• Maintained and updated QA databases• Recruitment of suitable staff and performance reviews Show less