Quality Assurance Manager

Quality Assurance ManagerFecha: 18 dic 2024
Your Tasks and Responsibilities: Transfer and assure the correct interpretation of the Compliance Management System (CMS) of Bayer HealthCare and its impact on the Site.Perform the Quality Management Review (Corrective and preventive Actions for Deviations, Trending of complaints product related, Counterfeiting, Recalls, Rejected Batches, Status of Validation Master Plans, etc).Check the changes in the Mexican Ministry of Health Law and worldwide regulations (ICH, FDA, INVIMA, ANVISA, TGA, etc) to identify the impact on the QMS and the actions needed for regulatory compliance.Implement training programs for QA & QC and Distribution Center Warehouse personnel according to individual needs.Supervise and coordinate the technical documentation needed in the dossiers (National & International).Ensure that medical and medicinal devices for human use are of the quality required for their intended use.Assure that the dossiers are ready for submission from the technical point of view.Guarantee compliance with governmental regulations (National and International).Protect the company from economic damage or legal consequences.Who You Are: Bachelor's degree in Pharmaceutical, Microbiology, or another similar field.At least 5 years of experience in Quality systems, GMPs, Training, Product Quality Review.Advanced level of English is required.Other: Negotiation skills.Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity and you have the "Passion to Innovate" and the

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