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QC Partner
Full-Time
Seoul, South Korea
Department
Health & Biotech
Job Category
Health & Biotech
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16 November 2023
Description
QC testing for biological/chemical drug products (ID/Purity by CE, HPLC & UPLC, Content by UV/Vis, Cell based Assays, etc.)
Management of QC equipment qualification, calibration, performance check and preventive maintenance
Both internal and external analytical method transfer exercise as a SME
Technical review of QC raw data
Internal or external GxP auditor/co-auditor
Various QC SOP, work instruction, protocol, and report generation/revision (as necessary)
Handling of deviation, OOS investigation, change control and risk assessment
Adhere to the current GxP good documentation practices and data integrity requirements
Management of QC material: QC sample/Retention sample, critical reagents, & cell banking
A member of local QRM (Quality Review Meeting)
Collaboration work with RA: Preparation of specification and test method for drug product
Qualifications
Basic qualification: Bachelor of Science majored in biotechnology or related science
A minimum of 5 years experience in developing and executing quality control operation, and laboratory experience in pharmaceutical company
A strong background and in depth knowledge in Instrumental analysis (HPLC, UV, CE, Spectrophotometer, Plate Reader, etc.)
Good Korean & English written and communication skills
Apply
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