Responsibilities:
• Under general supervision, maintains Quality Assurance System to ensure compliance with company and cGMP standards
• Responsible for regulatory authority inspections and external customer audit management, including inspection preparation, establish inspection support team, CAPA response submission
• Supplier audit and qualification management, including supplier performance review, approved supplier list & approved material list management, supplier audit schedule development and audit implementation, quality agreement management
• Self-inspection management, including self-inspection plan development and implementation, follow up the execution of CAPAs to the observations in self-inspection
• Manage the quality review of plasma center, including the on-site audit of critical materials in plasma center
• CAPA management and eQMS management, oversight the whole CAPA process, monitoring the CAPA KPIs, make sure CAPA are managed in an efficiency way
• Regulation monitoring, organize, coordinate, and supervise the gap analysis against new and revised GMP regulations, ensure the implementation of the identified measures
• Product Quality Reviews (PQR) & Drug Annual Report management
• Ensures standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements
• Executes training/awareness related to GMP standards
Qualifications:
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
• Knowledge of current Good Manufacturing Practices (cGMP) principles
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
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.
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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