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MSG
Roche
QC Partner
Full-Time
Seoul, South Korea
Health & Biotech
Health & Biotech
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
