With expertise in GxP (including GLP, GCP, GMP, GDP), Quality Management Systems, Regulatory Affairs, Risk Management, and more, I have a strong background in ensuring pharmaceutical and biotechnology compliance and quality. I excel in auditing, gap analysis, and remediation, facilitating project planning and implementation, and strategic planning. My international experience spans ASEAN countries, China, India, Japan, and Korea. I'm skilled in human resource management, budgeting, financial management, and analytical testing. Additionally, I have a comprehensive understanding of the pharmaceutical R&D process, technology transfer, and training development. My career encompasses a wide range of responsibilities, making me a valuable asset in the pharmaceutical and biotech industries.