Document Management Specialist
hace 1 día
**Summary**:Supports 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). -Supports the preparation and management of external and corporate audits and Health Authority inspections**About the Role**:**Major accountabilities**:- Planning and supporting PQR/APQR activities- Support site qualification and validation activities (planning, advising, review)- Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit)- Preparation/support and coordination of CAPA/follow-up- Audit and inspection preparation and support- Change control review/approval -Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.)- Ensure process quality assurance acc.- to regulations ,QP declaration review and approval,**Key performance indicators**:- Ensures planning and successfully supports PQR/APQR activities- Successfully carries out site qualification and validation activities (planning, advising, review)- Supports the implementation of Quality Systems (incl. documentation management);- Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc)- Ensure process quality assurance according to regulations**Minimum Requirements**:**Work Experience**:- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.- cleanliness zones.- Functional Breadth**Skills**:- Action Oriented.- Continuous Learning.- Dealing With Ambiguity.- Functional Skills.- Gmp Procedures.- Process Optimization.- Qa (Quality Assurance).- Quality Standards.- Self Awareness.- Technological Expertise.- Technological Intelligence.- GxP.- Industry standards.- Compliance requirements.**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.
-
Temporary Alliance Management Specialist
hace 3 días
Insurgentes, México Novartis A tiempo completo**Summary**: Location: Mexico City, #LI-Hybrid About the role: We are seeking an Alliance Management Specialist who will support to the strategic alliances' area in administrative work for the management of billing processes, forecasting, promotional materials, financial data monitoring, among others. **About the Role**: **Key responsibilities**: -...
-
Treasury Cash Management Senior Payments Specialist
hace 4 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:The TCM Senior Payment Specialist supports the Cash Disbursement end-to-end process within Novartis Global Service Center (NGSC), safeguarding its quality and effectiveness. The Senior Specialist acts as a role model for the Payments Team providing guidance, knowledge-sharing, empowerment to junior team members and continuously demonstrating...
-
Project Document Controller
hace 4 semanas
Insurgentes, México Johnson Controls A tiempo completoDocument ControllerHow You Will Do It:- Management and Implementation of the Document Control procedure, document workflows and work instructions that meet the Company requirements and Client Project Contractual obligations.- Development & management of a master database to reference all projects - past & present.- Manage production, storage and updating of...
-
Insurgentes, México Novartis A tiempo completo**Summary**: The TCM Senior Payment Specialist supports the Cash Disbursement end-to-end process within Novartis Global Service Center (NGSC), safeguarding its quality and effectiveness. The Senior Specialist acts as a role model for the Payments Team providing guidance, knowledge-sharing, empowerment to junior team members and continuously demonstrating...
-
Treasury Cash Management Payment Specialist
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:The TCM Payment Specialist supports the Cash Disbursement end-to-end process within Novartis Global Service Center (NGSC), safeguarding its quality and effectiveness. The role ensures that payments processes (entries, validation, quality, reporting and analysis) are in place and managed in accordance with defined standards and operating...
-
Quality Specialist
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**:We are seeking a detail-oriented Quality Specialist professional with a passion for delivering high quality outputs.The role requires strong testing experience, a deep understanding of SFMC architecture and ability to collaborate with cross functional roles and teams.**About the Role**:**Major Accountabilities**:- Design, develop, and execute...
-
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...
-
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...
-
Order Management Specialist
hace 5 días
Insurgentes, México Novartis A tiempo completo**Summary**:Proporcionar soporte analítico a la disciplina FRA para informes financieros, cumplimiento y precisión de datos. Manejar y coordinar la preparación de informes, asegurando su puntual presentación.**About the Role**:**Major Accountabilities**- Provide analytical support in matters related to supply chain activities, decision making.-...
-
Order Management Specialist
hace 5 días
Insurgentes, México Novartis A tiempo completo**Summary**: Proporcionar soporte analítico a la disciplina FRA para informes financieros, cumplimiento y precisión de datos. Manejar y coordinar la preparación de informes, asegurando su puntual presentación. **About the Role**: **Major Accountabilities** - Provide analytical support in matters related to supply chain activities, decision making. -...