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AGC Biologics is seeking a Quality Systems Supervisor to lead the Quality System Compliance team, focusing on GMP documentation and regulatory inspections in a biopharmaceutical environment. The ideal candidate should possess a Master’s degree in a scientific discipline and have over five years of relevant experience in quality assurance and documentation control.
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Job Summary
The role involves coordinating the Quality System Compliance team and managing the Self-Inspection process within a global biopharmaceutical organization.
Candidates must possess proficiency with the digital electronic system TrackWise for managing GMP documentation and archives.
AGC Biologics is a leading CDMO committed to delivering life-changing therapies through world-class development and manufacturing of therapeutic proteins and genetic materials.
Matching Summary
Match Score: 75
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AGC Biologics is seeking a Quality Systems Supervisor to lead the Quality System Compliance team, focusing on GMP documentation and regulatory inspections in a biopharmaceutical environment. The ideal candidate should possess a Master’s degree in a scientific discipline and have over five years of relevant experience in quality assurance and documentation control.
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Skills & Requirements
Must-have
Manage GMP documentation on TrackWise
Oversee periodic monitoring of quality KPIs
Manage CAPA management process
Lead self-inspection process
Act as subject matter expert during regulatory inspections
Nice-to-have
Exceptional attention to detail
Strong communication and interpersonal skills
Knowledge of Data Integrity standards
Experience with electronic document management systems