¢Ã ä¿ë Æ÷Áö¼Ç : QC Sr. Manager(ºÎ¼Àå)
Major
Responsibilities
• Lead QC organization with 20~30
associates to ensure product quality control is done according to the standard.
• Review & approval of QC
result of Biologics, Semi-finished goods & final products of rapid test,
ELISA assay and Urine analysis
• Review and approve Verification & Validation of Incoming
Materials
• Review the validation and verification test for process and
stability testing
• QC standard material (Panel) management
• Manage of Inspection/Audit and CAPA review and approval
• Transfer test method technology
• Review & approval
• Review and manage of QC Budget
Basic
Qualifications/ experience:
•
Leadership experience in QC (> 10 years) in bioindustry , medical device or
IVD
•
Experience in leadership role in organization more than 10 HC
•
Exceptional Communication skill in English (in
technical writing and conversation)
• Exceptional communication skills and
ability to facilitate cross-functional cooperation
•
Knowledge on GMP & ISO / Regulatory guidelines
•
Compressive knowledge Validation, Verification, Stability, Risk assessment,
CAPA and change control process based on ISO 13485:2016
• Global inspection experiences
*Çз : Over bachelor degree in relevant
major (Knowledge on diagnosis mechanism (Biological, Immunization)
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