Key accountabilities:

• 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.

Requirements:

• 
  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;

• Fluent written and oral English;

• Available for short term business trip.

上班地址：上海市外高桥保税区富特中路288号