▣ 채용 포지션 : QC Sr. Manager(부서장)

 

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

*학력 : Over bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization)

 

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