Simon Yu Email & Phone Number

Shanghai City, China

• Manage Roche Global Supplier of Chemical, Excipient, API and Medical Device in APAC region.
• Lead and perform audits of Roche suppliers according to the Supplier Quality Management Audit Program.
• Evaluate and solve a wide range of complex issues that affect multiple functions / sites related to material discrepancies and investigations in accordance with the applicable regulations, guidelines, cGMP standards.
• Initiate, assess, and manage vendor initiated change notifications in accordance with applicable regulations, guidelines, and Roche standards.
• Monitors the performance of suppliers and proactively collaborates with suppliers on continuous improvement projects to enhance the quality and supply of Roche materials.

Shanghai, China

• Supplier quality management experience for multi type supplier and CMO (APIs/Sterile APIs/Excipients/Medical Device) across the Asia-Pacific area.
• Schedule and Execute Hospira Supplier Audits in Asia-Pacific area as Lead Auditor.
• Provide audit and technical support across the region, cooperation with other regional functions.

Shanghai

• Lead and manage cGMP compliance project to implement cGMP practice involved in several key pharmaceutical companies in China
• Experience in business development of new project.
• Perform 3rd party Audits to APIs and Pharmaceutical plants (involved in audits for ASOCIACIÓN FORUM AUDITORIAS (AFA) and US/EU customers).