Quality System Specialist

职位 Quality System Specialist
分类 质量保证
汇报对象 Quality System Supervisor
工作地点 Suzhou

Responsible for providing a wide GMP and QMS coordination and ensuring that there is a satisfactory internal and external audit, quality system integrity to keep Suzhou site meet relevant regulatory, quality system and corporate expectations.

  • To maintain the adequacy and effectiveness of quality system for Suzhou site.
  • To coordinate internal and external audits, review and follow up any deviations in internal and external quality assessment to implement continuous improvement.
  • To assist change control management and supplier audit.
  • To assist management review and prepare all the relevant document.
  • To participate in all activities in compliance with relevant GMP and Quality System standards and specifically with local and FDA GMP.
  • To support site GMP, QMS compliance training.
  • Other tasks are authorized by superior.
  • Working experiences in pharmaceutical/medical device industry.
  • Strong knowledge of Chemistry and cGMP/GMP documentation requirements.
  • Qualification on internal audit and supplier audit.
  • Strong English and Chinese communication skills, reading, written, and verbal.