Cardurion Pharmaceuticals

Manager

• Execute requirements of Cardurion Quality Systems for GxP Document Management and the GxP Training Program
• Support development, implementation, and maintenance of Cardurion Quality Systems
• Facilitate development, review, approval, issuance, and maintenance of Quality System Policies and Procedures
• Provide technical and administrative support for eQMS users
• Administer the GxP Training Program through the eQMS, including training curricula management and training compliance reporting
• Serve as internal subject matter expert for GxP Document Management and GxP Training
• Ensure eQMS remains validated and compliant with documentation management requirements
• Develop and maintain SOPs, work practices, user guides, and training materials
• Train and troubleshoot for eQMS users
• Support document lifecycle activities and optimize document management processes
• Manage eQMS changes and functionality improvements in collaboration with Information Technology
• Fulfill GxP documentation requests and support regulatory inspections
• Monitor regulatory and industry requirements and trends
• Develop management reports for training compliance
• Collaborate with functional managers to develop and maintain role- or department-based training curricula
• Track the Quality Systems Plan and follow up on action items
• Support functional managers in developing SOPs and work practices

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