Quality Assurance Manager
Publication date:
21 October 2024Workload:
100%- Place of work:APAC, JP, Tokyo, CSL Behring
Responsibilities:
• Under general direction, leads/coordinates Quality Assurance activities in accordance with cGMP standards
• Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations
• Coordinates and manages complex deviations, task forces and communication to ensure compliant release system for corresponding market
• Responds to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release
• Supports submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.)
• Initiates changes to SOPs when a deviation from regulation is identified or a system process is not functional based on the current instructions
Qualifications:
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
• Experience within a global matrix organization
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of appropriate regulatory requirements
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
• Under general direction, leads/coordinates Quality Assurance activities in accordance with cGMP standards
• Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations
• Coordinates and manages complex deviations, task forces and communication to ensure compliant release system for corresponding market
• Responds to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release
• Supports submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.)
• Initiates changes to SOPs when a deviation from regulation is identified or a system process is not functional based on the current instructions
Qualifications:
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
• Experience within a global matrix organization
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of appropriate regulatory requirements
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
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As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
