Qc Senior Manager

MAIN 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

QUALIFICATIONS

Education

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

Experience/Background

• Leadership experience in QC (> 10 years) in bioi ndustry , 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

Preferred whom with