Melbourne, Victoria, Australia
Dynamic and results-driven professional with over 7 years of experience in the Pharmaceutical Industry with sound understanding of the regulatory requirements of the TGA, FDA, EMA and ISO-13485 ● Proven track record in quality assurance, quality control, and process improvement. ● Demonstrated expertise in validation, method development, adept at managing complex projects and ensuring compliance with regulatory standards. ● Enjoys building collaborative relationships and influencing outcomes, skilled in leading cross- functional teams and driving continuous improvement initiatives. ● Demonstrated expertise in data integrity, problem-solving, and staff development. ● Committed to delivering high-quality results and enhancing operational efficiency.
Responsible for ensuring the quality and adherence to process standards within Packing and Visual Inspection operations. Provided real-time issue resolution, process improvements, and providing support for quality escalations. Effective collaboration with manufacturing teams to enhance processes, conduct audits, and ensure compliance with batch release schedules.
Facilitated timely review and approval of batch records to meet batch release schedules. Supported troubleshooting and resolving quality-related issues, participating in investigations, and ensuring continuous improvement in QC processes. Involved in qualification, validation and verification activities to supported the introduction of new materials and test procedures. Developed and optimised scheduling of tasks by acting as standard work champion.