WuXi AppTec

  • Assistant Director, Quality Systems

    Job Locations CN
    Job ID
    2018-4106
  • Overview

    Direct leader: QA Director
    Subordinate: QA Specialists/Sr. QA specialists in Quality Systems (Document Management/Archives, Deviation/Change Control/CAPA, Metrics, Electronic systems management, Training management)

    Responsibilities

    • Manage the daily operations of the Quality systems functions in the areas of:
      • Overall setup and management of Quality Systems group and functions
      • QA document control and document archives for GMP operations
      • Periodic quality metrics and document review,
      • Development and maintenance of GMP training and company annual training plan;
      • Change control, deviation and CAPA management;
      • Electronic Systems Implementation and Maintenance for GMP operations
      • Assistance in audits/inspections for internal audit, external audits (client/regulatory agencies), and follow-ups;
    • Provide supervision to the Quality systems group to achieve defined department and corporate goals
    • Act as a QA representative (QAFL/QA Sponsor) on CMC projects and communicate with directly with clients about quality issues and updates
    • Complete assigned tasks by area management in a timely manner

    Qualifications

    • With the education background of medicine or relevant major of bachelor or above, with more than 2 years related working experience, familiar with the GMP/cGMP/EU GMP regulations;
    • Pass the all examinations before onboarding (healthy check , references/background check);
    • Expertise in Microsoft Office suite (word, excel, powerpoint) and MS visio
    • Good communication skill in English and Chinese, both in writing and verbally.
    • Good interpersonal and communication skills; work well in a team setting as well as the ability to work independently with minimum supervision

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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