Quality Assurance Manager
Vifor (International) AG
Veröffentlicht:
21 Oktober 2024Pensum:
100%- Arbeitsort: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.
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Kontakt
Vifor (International) AG