QA Audit Specialist
- 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.
- 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