Quality Assurance Manager
Your task and Responsabilities:
To transfer and assure the correct interpretation of the Compliance Management System (CMS) of Bayer HealthCare previously do an impact in the Site.
To performance 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).
To check the changes in the Mexican Ministry of Health Law and worldwide regulations (ICH, FDA, INVIMA, ANVISA, TGA, etc) to identify the impact in the QMS and the actions needed to carry for the regulatory compliance.
To implement all the training programs for the QA & QC and Distribution Center Warehouse people accordingly with the individual necessity.
To supervise and to coordinate the technical documentation that is needed in the dossiers (National & international).
To ensure that medical and medicinal devices for human use are of the quality required for their intend use.
To assure that the dossiers are ready for submission from the technical point of view.
To guarantee the compliance with governmental regulations (National and international).
To protect our company from economic damage or legal consequence.
Who you are:
Bachelor's degree in Pharmaceutical, Microbiology or another similar career
Experience at least 5 years in Quality systems, GMPs, Training, Product Quality Review.
Ingles: Advance Level is needed
Other: Negotiation
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 "Power to Change", we encourage you to apply now. Job Postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies Bayer does not accept unsolicited third-party resumes.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Bayer Is committed to providing access and reasonable accommodations in its applications process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodations using the contact information below.
Período de aplicación:
18 al 8 de enero del 2025
Código de referencia:
836147
División:
Consumer Health
Ubicación:
Mexico : Estado de Mexico : Toluca
Área funcional:
Registro Farmacéutico
Grado de posición:
VS 1.3
Tipo de empleo:
Permanente
Tiempo de trabajo:
Full Time