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).