Devlin Gardner

Background

About Devlin Gardner

Strong, experience based, knowledge/development of pharmaceutical and cosmetics manufacturing systems and practices to meet regulatory compliance PIC/S PE-009 & ISO 22716 based cGMPs in Australia. Extensive knowledge of and experience in the implementation and management of ISO13485 Medical Devices, ISO9001, GMP, HACCP, Food and TGA & APVMA licensing systems and standards. In depth knowledge of development, qualification and validation of EO gas sterilization systems. In depth experience managing in a chemical plant operation with respect to production management, resource management and personnel management including new product development, OHSMS and QMS development and management. Experience in implementing OHS systems towards legislative compliance and integrated risk management. Extensive experience of managing sales, business and new market development in chemical sectors and new medical device product development and registrations (EU, FDA and TGA). Experience in computerized automation of plant and equipment, encompassing instrumentation, supervisory control and data acquisition (SCADA). Familiar with a wide range of unit processes and raw materials used in the chemical industry. Specialties: Pharmaceutical Quality and Regulatory Compliance - GMP, Sterilization Systems development (EO), HACCP, FOOD and ISO 9001/13485 development and administration, Production management, Plant and Industrial Chemistry.