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Mgr QA Shanghai China,  

Amgen (company)

Posted on : 01 May 2017

Project Description

  • Perform quality oversight and audit of key suppliers to company and its subsidiary companies. 
  • These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc.
  • Apply an advanced knowledge of Chinese and global market regulations to assess supply security risks;
  • Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of company suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.;
  • Monitor new and/or revised China regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Chinese Pharmacopoeia requirements;
  • In collaboration with globally located company sites, support on identifying, assessing and addressing supplier GMP/GDP risks;
  • Support our company management and stakeholders with guidance and interpretation on above standards and trends, as well as their implementation and enforcement;
  • Execute necessary tasks and projects as assigned, to assist in the timely attainment of group, department, team and corporate goals;
  • Provide support for regulatory inspections of key facilities as needed


China Shanghai

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