Sr. Global Gmp Auditor
hace 3 semanas
**Summary**:- Manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) -Lead the preparation and management of external and corporate audits and Health Authority inspections.**About the Role**:**Major accountabilities**:- Oversight and implementation of Quality Management System -Incident management.- GxP Audit and inspection management -Site Regulatory oversight (incl. Reg-CMC facilitation) -Exception management -Supplier Quality management (local) -Qualification and validation -Quality Compliance -Data Integrity and eCompliance -Site KPI / KQI maintenance / reporting -Initiate and drive local hiring process -Line responsibility and daily walkthrough -Lead OpEx Projects -Investigation of Deviation, OOx, Complaints -Define and implement CAPAs -Support transfer projects and validation studies -Track team metrics and ensure KQI/KPI meet requirements -Review and approve text and design -HSE incidents reporting and action follow-up -New equipment commissioning support (OQ, PQ) -Define improvement areas in process and products -Resource and capacity (people and equipment) planning and workload management -Performance and leadership support to specialist team -Ensure availability of equipment, chemicals and consumables, as appropriate -SOP review and revision -Perform local training and monitor training status -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)**Key performance indicators**:- Successful support of projects with agreed quality and delivery dates, passing of internal and external inspections.- Meet quality and timelines for all projects.- Act in accordance with Novartis standards.- The number and severity of cGMP issues identified during internal and external audits -Year-end figures within budget.- Successful coordination of departmental operational activities**Minimum Requirements**:**Work Experience**:- Functional Breadth.- People Leadership.- Project Management.- Collaborating across boundaries.- Critical Negotiations.- Operations Management and Execution.**Skills**:- Agility.- Auditing.- Business Acumen.- Business Partnering.- Collaboration / Teamwork.- Communication Skills.- Compliance Audits.- Continuous Learning.- Dealing With Ambiguity.- Decision Making Skills.- Employee Performance Evaluations.- Finance Acumen.- Gmp Procedures.- Goal Oriented.- Health Authorities.- Leadership.- Logical Thinking.- Major Incident Management.- People Management.- Problem Solving Skill.- Problem Solving Skills.- Qa (Quality Assurance).- Self Awareness.- Smart Risk Taking.- Stakeholder Management.- Technological Expertise.- Audit Management.- Inspection Readiness.- Product release.- Organizational skills.**Languages**:- English.DivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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Sr. Global Gmp Auditor
hace 3 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:~ Gestionar las actividades, operaciones y sistemas rentables de cumplimiento y/o auditoría de GxP para garantizar el cumplimiento de las áreas de negocio con el Manual y las Políticas de Calidad de Novartis y todos los requisitos relevantes de GxP, legales y reglamentarios, y a través de auditorías internas, KPI (Indicadores clave de...
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Sr. Global Gmp Auditor
hace 3 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:~İş alanlarının Novartis Kalite El Kitabı ve Politikaları ile ilgili tüm GxP, yasal ve düzenleyici gerekliliklere uygunluğunu sağlamak için ve iç denetimler, KPI'lar (Anahtar Performans Göstergeleri) ve KQI'ler (Anahtar Kalite Göstergeleri) yoluyla uygun maliyetli GxP Uyumluluğu ve/veya Denetim faaliyetlerini, operasyonlarını ve...
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Sr. Global Gmp Auditor
hace 3 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:~Gestire attività, operazioni e sistemi di conformità GxP e/o audit convenienti per garantire la conformità delle aree aziendali al Manuale e alle politiche di qualità di Novartis e a tutti i requisiti GxP, legali e normativi pertinenti, nonché attraverso audit interni, KPI (Key Performance Indicators) e KQI (Key Quality Indicators)~Guidare...
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Sr. Global Gmp Auditor
hace 3 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:~Gérer les activités, opérations et systèmes rentables de conformité GxP et/ou d’audit pour assurer la conformité des secteurs d’activité avec le manuel et les politiques de qualité de Novartis et toutes les exigences GxP, légales et réglementaires pertinentes, et par le biais d’audits internes, d’indicateurs clés de...
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Quality Management System Sr Specialist
hace 4 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:- Ensure the implementation, control and maintenance of the Quality System at Novartis, in accordance with current regulatory requirements, both national and international, and the guidelines of the Corporate Quality Manual that ensure and evidence the quality of the products marketed in Americas region and compliance with established...
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Regional Logistics Manager
hace 1 semana
Insurgentes, México Novartis A tiempo completo**Summary**: Step into a role where your strategic planning and logistics expertise directly impact patient care. As Planning & Logistics Manager, you’ll be at the heart of ensuring timely and compliant delivery of RLT products across the region.. This includes balancing risk and cost based on available production capacity, lead times, and regulatory...
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Tax & Statutory Reporting Sr. Specialist English Speaker
hace 1 semana
Insurgentes, México Sandoz A tiempo completo¡En 2023 #Sandoz se convirtió en una organización independiente! Como líder del mercado mundial de medicamentos genéricos y biosimilares, Sandoz da un paso adelante desde una posición de fortaleza. Quienes se unen a Sandoz colaboran con el futuro de la empresa, su crecimiento, innovación, cultura y cómo Sandoz impacta las vidas de millones. ¡Estas...
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Deviations Specialist
hace 2 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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Fra Sr. Specialist O2c
hace 1 semana
Insurgentes, México Novartis A tiempo completo**Summary**: - O2C Sr. specialist will be responsible for execution collections and achieve targets while deliver service to our international and external customers. Following complex customers and executing tactics and strategies as often as necessary, including but not limited to virtual meetings, visits and document agreements, resolution of problems...
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QA Manager
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**: - Assurance that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP **About the Role**: **Major...
