WuXi AppTec

  • Auditing Associate Director

    Job Locations CN-Shanghai
    Job ID
    2018-4108
  • Responsibilities

    • 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.

    Qualifications

    • 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

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