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
- Job type:Graduate Jobs
Pharmacy and Pharmacology
Seoul (South Korea)
- Closing Date:9th Jul 2022, 6:00 pm