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Quality System Specialist - China  

Amgen (company)

Posted on : 26 August 2017

Project Description

Amgen is a leading global biotechnology company, with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses. Our medicines have made a dramatic difference in the lives of millions. To underpin our commitment to serve patients in China, Amgen is now establishing a Research and Development facility in Shanghai. The Amgen Shanghai facility will have a Translational Science focus with modern molecular and cellular science and pathology laboratories, designed to discover and develop valuable biomarkers in support of clinical programs.

Amgen R&D Shanghai Translational Sciences is looking for a Quality System Specialist dedicated to clinical biomarker development. The primary responsibility will be ensure quality and compliance of company sponsored clinical trials in a compliant manner, and participate in both internal and external collaborations in support of multiple biomarker development projects in China.
An in-depth knowledge and clear understanding of applicable domestic and international GCP/GLP regulations and guidelines (ICH).
Professional to develop and set up the QMS (Quality Management System) in house with a particular focus on GCP continuous improvement.
Participating in the evaluation and qualification of CROs and other service providers.
Assist clinical Ops in the development of clinical SOPs and other quality documents.
Performing assays if needed.
The successful candidate must display a strong entrepreneurial spirit, multi-tasking skills, in line with Amgen’s pursuit of scientific/quality excellence.