Expertise That Powers Progress
About
Yvonne Woo Consulting combines technical expertise with user-focused design to deliver streamlined documentation and technical support solutions. The consulting firm will help biotechnology and pharmaceutical companies boost productivity and efficiency by aligning services with real-world operational needs.
Dr Yvonne Woo is a highly technical and innovation-driven professional, known for her unique blend of expertise across multiple scientific and operational domains. Leveraging her multidisciplinary background, she excels at driving innovation initiatives, aligning cross-functional teams and consistently delivering high impact outcomes on complex projects. In addition, Yvonne's multilingual skills have provided valuable support to local and international companies with documentation and translation needs.
Yvonne began her career as an Immunologist, mentored by world-renowned experts in the field, where she gained extensive experience in vaccine development and coordinating vaccine clinical trials for infectious diseases and cancers. As her career progressed, she was motivated by the impact she could make in Manufacturing and Facility Operations. Since then, she has held pivotal roles in Research and Compliance, executing Operational Readiness activities for new facilities, leading continuous improvements to workflows and processes to drive Operational Excellence and developing Work Health and Safety Management Systems.
With a strong foundation and a clear vision ahead, Yvonne Woo Consulting is eager to take on opportunities that will push boundaries and create legacy of impact on biotechnology and pharmaceutical industries.
Yvonne Woo, PhD.
Qualifications/Certifications/Affiliations
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Bachelor of Science (Hons) - First Class (Microbiology)
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Doctorate of Philosophy (Immunology)
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UQ Adjunct Research Officer/Fellow: 2007-2022
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Auditor
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Health and Safety Representative
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ICH GCP Study Coordinator
Core Services
Explore our range of consulting services tailored to meet your business needs.
GMP-Compliance
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PIC/S and TGA
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Site Master Files
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Contamination Control Strategy
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Cross-Contamination Controls
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Quality Management Systems
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Policies
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Standard Operating Procedures
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Work Instructions
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Risk Assessments
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Manufacturing process flow diagrams
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Registers and forms
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Specifications documentation
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Mock TGA audits, third-party or internal audits and supporting/lead back room activities
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Materials/Incoming goods documentation
Operational Readiness
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Laboratory Readiness
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Cleanroom Readiness
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Warehouse Readiness
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Waste management
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Pest control management
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Storage of materials and products
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Cleaning processes
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Equipment management processes
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Training programs
Work Health and Safety Support
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WHS Management Systems
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Chemical Management Systems
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WHS Policies
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WHS Management Plans
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WHS Procedures
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WHS Risk Assessments
Past Projects
TGA Readiness Project
Partnered with Quality Assurance team to established a comprehensive documentation framework through detailed process mapping, ensuring compliance and regulatory standards. Provided critical support in the preparation and implementation of Quality Systems and documentation, contributing to the attainment of the TGA Manufacturing Licence during tenure at Vaxxas.
Operational Readiness Project
Led Operational Readiness team in documentation transfer, system establishment and training programs during the transition to the new 5000m² Vaxxas Biomedical Facility. Implemented robust processes and training programs to ensure operational safety, regulatory compliance and readiness. Supported key operational areas such as Cleanrooms, Laboratories and Warehouse ensuring adherence to GMP requirements and efficient workflow management.
GLP-Compliance Laboratory
Established a GLP-Compliant Laboratory during transition to the commercial space at Translational Research Institute (TRI). Developed SOPs, implemented WHS documentation framework and conducted detailed risk assessments to ensure safe, compliant and efficient laboratory operations.
Vaccine Clinical Trials
Coordinated vaccine clinical trials under Emeritus Professor Ian Frazer, overseeing cross-functional collaboration with clinicians, clinical nurses and scientists. Acted as Sponsor Representative for site audits and trainer for human sample processing, contributing to clinical data pivotal to the Jingang Medicine's successful investor presentation and subsequent acquisition.
