Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • Obey Company discipline;
  • Be responsible for planning, arrangement and execution of project self-inspection;
  • Be responsible for summarizing findings raised during project self-inspection, establishing written audit report and follow-up the implementation of the correction activities;
  • Be responsible for documentations preparation and answering related questions of the PD quality system in CFDA onsite-verification;
  • Be responsible for summarizing findings and questions from auditors and send it to the related department directors and FLs in a timely manner;
  • Be responsible for periodical review of CFDA onsite-verifications;
  • Be responsible for coordinating and performing training to different departments;
  • Be responsible for review and revision of related SOP;
  • Report to direct leader of job periodically;
  • Other works assigned by direct leader.

 

Basic Qualifications:

  • With the education background of medicine or relevant major of bachelor or above, with more than 2 years related working experience in QA auditor or drug registration, familiar with the GMP regulations and guidelines (CFDA/Eudrax/FDA /ICH etc) and guidelines;
  • Good communication and coordination skills;
  • With good English and Chinese listening, speaking, reading and writing ability.

Primary Location: China – Shanghai

To apply please send your application to HR_Biologics@wuxiapptec.com

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