Deviations Specialist
hace 9 horas
**Summary**:The Deviations Specialist/ QA Investigator is responsible for managing and executing investigations of deviations and non-conformities within manufacturing and quality control environments. This role ensures root causes are identified, corrective and preventive actions (CAPAs) are implemented effectively, and documentation complies with cGMP and Novartis standards.**About the Role**:**Key Responsibilities**:- Lead and document investigations related to deviations.- Perform root cause analysis using tools such as 5 Whys, Fishbone, FMEA, etc.- Collaborate with cross-functional teams (Production, QC, QA, RA, Supply Chain, Engineering, etc.) and international teams (e.g., Argentina, Chile, U.S.) to gather data, perform root cause analysis and drive timely resolution of investigations.- Ensure CAPAs are defined, implemented, and verified for effectiveness.- Maintain investigation records in compliance with internal procedures and regulatory expectations.- Establish and monitor quality KPIs.- Provide guidance to Business Partners in the activities related to Deviation process to stablish improvements.- Act as key user for the deviations system, managing access and troubleshooting.- Support audits/inspections with documentation and participation in discussions.- Identify trends and recurring issues to support continuous improvement initiatives.- Contribute to the development and revision of SOPs related to deviation and CAPA management.- Foster digitalization and the use of artificial intelligence (AI) within a global framework to optimize and streamline processes.- Support service implementation and transitions (knowledge transfer, go-live, hyper-care).**Specific skills and qualifications**:- Bachelor’s degree in pharmacy, Chemistry, Biology, or related scientific discipline.- Minimum 4 years in pharmaceutical QA (preferably in deviation/CAPA management, GMP, regulatory compliance), local/international Health Regulations and Project management.- Strong knowledge of cGMP, ICH, and regulatory standards.- Experience with electronic quality systems (e.g., 1QEM, SAP-QM).- Excellent analytical, communication, and documentation skills.- Skilled in cross-functional collaboration and process optimization.- Familiar with business intelligence, design thinking, agile methodologies, and data management.- Digital skill- High responsiveness and customer satisfaction.- English proficiency and Portuguese (desirable).**Skills Desired**Aprendizaje continuo, Autoconciencia, Dealing With Ambiguity, Estándares de calidad, Inteligencia Tecnológica, Procedimientos GMP, Pruebas de control de calidad (QC), QA (Aseguramiento de la Calidad), Technological ExpertiseDivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo**Ajustes de accesibilidad**:
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Deviations Specialist
hace 1 semana
Insurgentes, México Novartis A tiempo completo**Summary**: The Deviations Specialist/ QA Investigator is responsible for managing and executing investigations of deviations and non-conformities within manufacturing and quality control environments. This role ensures root causes are identified, corrective and preventive actions (CAPAs) are implemented effectively, and documentation complies with cGMP and...
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Deviations Specialist
hace 7 días
Insurgentes, México Novartis A tiempo completo**Summary**:The Deviations Specialist/ QA Investigator is responsible for managing and executing investigations of deviations and non-conformities within manufacturing and quality control environments. This role ensures root causes are identified, corrective and preventive actions (CAPAs) are implemented effectively, and documentation complies with cGMP and...
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QA Deviations Specialist
hace 4 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:The Deviations Specialist/ QA Investigator is responsible for managing and executing investigations of deviations and non-conformities within manufacturing and quality control environments. This role ensures root causes are identified, corrective and preventive actions (CAPAs) are implemented effectively, and documentation complies with cGMP and...
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QA Deviations Specialist
hace 10 horas
Insurgentes, México Novartis A tiempo completo**Summary**: The Deviations Specialist/ QA Investigator is responsible for managing and executing investigations of deviations and non-conformities within manufacturing and quality control environments. This role ensures root causes are identified, corrective and preventive actions (CAPAs) are implemented effectively, and documentation complies with cGMP and...
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QA Deviations Specialist
hace 4 semanas
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QA Deviations Specialist
hace 4 semanas
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QA Deviations Specialist
hace 4 semanas
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QA Deviations Specialist
hace 4 semanas
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QA Deviations Specialist
hace 4 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:~Gérer les aspects et les projets de qualité dans le domaine de responsabilité.~ Assure et soutient la conformité globale GxP et la conformité aux systèmes de gestion de la qualité de Novartis.**About the Role**:Major Accountabilities~ Supervision de toutes les activités de production et de test, assure la conformité avec cGxP, y compris...
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QA Deviations Specialist
hace 4 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:~Gestiona aspectos de Calidad y proyectos dentro del área de responsabilidad.~ Garantiza y respalda la conformidad general de GxP y el cumplimiento de los sistemas de gestión de calidad de Novartis.**About the Role**:Major Accountabilities~ Supervisión de todas las actividades de producción y pruebas, garantiza el cumplimiento de cGxP,...
