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CW-Quality Associate

The Programme 

Implementation and on-going management of Quality Systems at Amgen Korea as per GxP regulations of South Korea as well as Amgen policies. 

What You Will Do 

  • Implement and support product sample delivery for import testing's and method transfers to contract lab. 
  • Manage local contract labs and warehouse (day-to-day testing/communication, KPI, etc.). 
  • Support and implement reagents, reference standards and samples importation to Korea. This includes communication with broker, shipper and relevant authorities. 
  • Manage and own quality documents including local SOPs, local APRs, Vendor Review Documents, Disposition Packets, etc. 
  • Support quality regulatory inspections, corporate audits, vendor audits, etc. 
  • Manage and support the product complaint processes for South Korea including intake, sample management, communications, etc. 
  • Support product recall and mock recall. Participate in the communications with global recall team, especially when the main QP is away.
  • Manage and deviation records and change controls per applicable procedures. 

Required Skills and Abilities 

  • A minimum of a Bachelor’s degree. The degree in Chemistry, Biology, Pharmacy or related scientific field desirable but not required. 
  • Verbal and written communication skills in English.  Business language level desirable. 
  • Basic IT skills (e.g., Microsoft Outlook, Word, Excel, PowerPoint, etc.). 
Closing in 12 days
Closing in 12 days
  • Job type:Graduate Jobs
  • Disciplines:

    Pharmacy and Pharmacology

  • Citizenships:

  • Locations:

    Seoul (South Korea)

  • Closing Date:9th Jul 2022, 6:00 pm

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