Isabella Li Email & Phone Number

Melbourne, Vic, Au

Melbourne, Victoria, Australia

Melbourne, Australia

• Responsible for overseeing, monitoring and delivering clinic objectives.• Review of current healthcare legislations and implementation to practice standards and services.• Provide administrative support to practice manager and principal practitioners, such as meeting coordination, including minute-taking.• Assist in identifying and providing quality advice on quality of care, and actively development optimisation alternatives.• Development and updating of existing resources such as website information, brochures and patient information kits.

Australia

• Supported and managed new product development and reformulation of existing Laminex portfolio, following stage gate processes from conception to launch.• Develop new product PRS, TRS to present to marketing and sale for alignment in launch and collateral preparation. • Established document control procedures for technical papers to leverage existing knowledge for future project pipeline.• Developed team stage-gate reports and documentation for research and innovation departments to ensure all stages of the project life cycle were accounted for.• Developed templates and budget trackers to ensure financial transparency and enable accurate future forecasting. • Test method development for prototyping and competitor benchmarking activities, including canvassing across multiple industries and standards. • Coordinated with quality and other stakeholders to ensure new product portfolio is aligned with company strategy and forecast.

Australia

• Provided training and support to staff on document control procedures and system usage, promoting adherence to best practices and regulatory requirements.• Designed and implemented development template for product architectures and technology platform to streamline NPD Projects.• Provided guidance for continuous improvement initiatives on production, with use of SPC software• Successfully transferred formulation from New Zealand to Australia, implementing new technology and support stability testing protocols. • Consulted with external partners to procure product/ingredient information, facilitate sampling, set up new product developments.• Liaised with operations team to coordinate on-site trials to fast-track implementation timeline, utilising existing plant capabilities to drive process optimization.

• Batch record review, impact assessments in events of non-conformances. • Initiation and consultation of non-conformance reports with quality assurance teams• Facilitated internal and external audits within production lines to maintain certification and compliance.• Understanding of Design control, Validation and Verification processes, and Quality Management Systems (ISO13485), GLP and GMP requirements.• Devised and implemented strategies to minimise operator error through automation of Batch History Records and documentation.• Represented reagent formulation team’s interest and assisting in meetings for process deliverables as set by operations and engineering departments. • Liaised with multiple stakeholders within different departments to guarantee project deliverables were achieved.• Developed of new processes in formulation, resolution of technical issues during project stages, and training for scale-up activities.

Australia

The Monash Industry Team Initiative (MITI) partners multidisciplinary student teams from Monash University with leading Australian and global industry partners. Students collaborate and design innovative solutions to real issues in today's business world.Burra Foods’ wastewater treatment plant routinely receives volumes and milk solids which stress its design capability This project allowed further understanding of routine milk solids losses to wastewater and, through application of a waste minimisation hierarchy, we identified reduction opportunities. A reduction in milk solids losses provided twin financial benefits of yield improvements and wastewater treatment plant cost reductions.

Victoria, Australia

Over the summer, I had the opportunity of working at IDT under the Monash Summer Research Scholarship to gain exposure in working in a pharmaceutical manufacturing setting. During this time, I was largely involved on researching about GMP requirements and legislation to allow for product introduction and development, in addition to assisting in process validation.

Bachelor'S Degree, Pharmaceutical Sciences, 2Nd Class Honours

Bachelor'S Degree (Honours), Chemical Engineering, 2Nd Class Honours