• Be responsible for management of GMP Self-Inspection (internal audit);
• Be responsible for coordinating and participating supplier audit, including material providers, outsourced testing laboratory, metrological supplier, and carrier;
• Be responsible for Scheduling, preparation and hosting client audit and regulatory inspection;
• Be responsible for response to observations and follow-up with CAPAs to client audit and regulatory inspection;
• Be responsible for management of routine inspection;
• Be responsible for maintenance and explanations of related SOPs;
• Be responsible for searching and collecting GMP information as to most up-to-date intelligence, regulation and guidelines etc.

• With the education background of medicine or relevant major of bachelor or above, with more than 10 years related working experience in cGMP quality management, familiar
• with the GMP regulations and guidelines (CFDA/EU GMP/FDA/ICH etc.);
• With 3+ years of management experiences in managing a team;
• Familiar with the operation of statistical software and office software;
• Problem-analyzing and solving ability, Good communication and coordination skills;
•  luent written and oral in English and Chinese;
• Available for short term business trip.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled