Pact's APM Contract Manufacturing division manufactures and packs for nutraceutical, herbal, vitamin, mineral and nutritional supplements. Tablets, hard capsules and powdered products are produced in our in our state of the art, TGA compliant facility in Keysborough.
Our uniquely flexible and purpose-built facilities utilise the latest blending, granulating and packaging technologies, allowing us to maintain the fastest project completion times in the industry.
About this opportunity
We are seeking a Quality Manager to Lead the Quality team and work with other functional areas to ensure products are consistently produced in compliance with marketing authorization and GMP requirements. The Quality Manager is responsible for release to market and for the Quality Assurance Systems of Australian Pharmaceutical Manufacturers and is the delegate on the Therapeutic Goods License for Quality Control.
Your key responsibilities will be to:
• Develop and implement quality management strategy and plans, including resource, systems, timescales, to support, contribute to, and integrate within, the company’s business plan and long-term strategy
• Implement and maintain the Quality Assurance Systems.
• Ensure that GMP Agreements are in place with customers, contract manufacturers and laboratories and that appropriate service agreements are in place with all service providers to the business that impacts on Quality.
• Monitor and report on compliance to standards
• Establish and implement necessary communication strategy for the improvement and awareness of quality issues across all departments through the companies training program
• Report as necessary on changes in standards (internally and externally initiated) and on performance against standards
• Liaise and co-operate with quality management and standards bodies (e.g. TGA, Government Departments)
• Manage departmental performance against agreed targets and budgets, and within policies and standards
• Ensure Product Quality Reviews are conducted routinely and are in compliance with regulatory standards for all medicines produced by Australian Pharmaceutical Manufacturers.
• Contribute to executive policy and strategy for the business.
• Work closely with purchasing staff in establishing quality requirements for external suppliers
• Work closely with QC and Purchasing to ensure that the Vendor Assurance program for the company is being maintained and is in compliance with all regulatory requirements
• Ensure that all necessary testing is carried out in accordance with pre-determined requirements
• Approve and authorise specifications, sampling instructions, test methods and other Quality Control procedures
