Your role:

• In charge of quality system operation and continual improvement, including deviation and CAPA management etc. to ensure the product quality and system compliance withinternal requirement and customer expectation.
• In charge of participation and implementation of self-inspection, internal audit and external inspection activities. Ensures that audits are performed per developed schedule. Review findings and makes recommendations for findings. Ensures timely response and closure of all action items / commitments.
• Draft and review of quality system related documents
• Support on site quality index and performance monitoring and Quality Council organization to maintain the process of management review
• Lead the management of routine quality affairs: including the management of deviations, CAPA, change control, risk assessment, and other quality activities. To evaluate impact of deviations, OOS results and changes on product quality attributes.
• Perform daily on spot inspection in commercial manufacturing, monitor the process, environment, equipment, e-system implementation and etc.; point out the non-compliance issues timely and follow up the corrections. 
• Review batch manufacturing records and associated documentation in support of batch disposition.
• Participate in the disposition process of rejection and site level RCA from the complaint management.
• Take part in the site project from quality aspect ,such as new product TT transfer project, material localization project, new electronic system project …，take part in the risk assessment, and ensure the suitable action plan are defined to reduce the quality risk to the business.
• Complete additional work assigned by superior.

Who you are:

• BS in Pharmaceutical or equivalent.
• 5+years quality experience in pharmaceutical, medical device, or life science industry.
• Excellent communication, problem-solving, planning and organization skills
• Fluent in English, both of written and oral
• Familiar with electronic Quality system.