鲁晓宇 Email and Phone Number

Thorough knowledge of GMP compliance. Leading change control management and investigation as well as CAPA follow up. Leading Suzhou site successful inspection for FDA, CVM and MOA. Experience in oral product and aseptic product manufacturing and environmental monitoring. Working experience in multiple pharmaceutical companies.Regulatory and registration experience for global supply manufacturing. Good working experience with the animal health regulation in China. Attended the session hosted by China MOA for GMP guideline revise, policy draft as GMP expert. Supported several Chinese sites in quality operation and due diligent of joining venture firms and contractors. Successful transfer more than 20 products from other five sites and launched on time.Advanced in managing multiple projects, prioritizing work, goals and tasks and controlling schedule. Providing an effective and efficient QO service to the site by leading, directing, developing and coaching the QO team. Build strong site quality culture and quality system. Communication with multiple internal divisions and management local China suppliers.