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Mgr QA - China  

Amgen (company)


Posted on : 01 May 2017

Project Description

Perform quality oversight and audit of key suppliers to Amgen 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 Amgen 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 Amgen sites, support on identifying, assessing and addressing supplier GMP/GDP risks;Support Amgen 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;Travel to Amgen sites and vendor locations within and outside China;

Locations

China Shanghai

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