ㆍ Lead QC organization with 20~30
associates to ensure product quality control is done according to the standard
ㆍReview &
approval of QC result of Biologics, Semi-finished goods & final products of
rapid test, ELISA assay and Urine analysis
ㆍReview and
approve Verification & Validation of Incoming Materials
ㆍReview the
validation and verification test for process and stability testing
ㆍQC standard
material (Panel) management
ㆍManage of
Inspection/Audit and CAPA review and approval
자격요건
ㆍCareer : >15 years
ㆍOver bachelor
degree in relevant major (Knowledge on diagnosis mechanism (Biological,
Immunization))
ㆍEnglish
proficiency and pharmaceutical company experience required
ㆍLeadership
experience in QC (> 10 years) in bioindustry , medical device or IVD
ㆍExperience in
leadership role in organization more than 10 HC
ㆍExceptional
Communication skill in English (in technical writing and conversation)
ㆍExceptional
communication skills and ability to facilitate cross-functional cooperation
ㆍKnowledge on
GMP & ISO / Regulatory guidelines
ㆍCompressive
knowledge Validation, Verification, Stability, Risk assessment, CAPA and change
control process based on ISO 13485:2016
ㆍGlobal
inspection experiences
우대사항
ㆍProven leadership capability
ㆍWork
experience in global company
