Deviations Specialist

hace 4 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 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 Expertise

Division

Operations

Business Unit

Innovative Medicines

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Ajustes de accesibilidad**:

  • 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...

  • QA Deviations Specialist

    hace 3 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...

  • QA Deviations Specialist

    hace 3 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**:~Upravlja vidike kakovosti in projekte znotraj področja odgovornosti.~Zagotavlja in podpira splošno skladnost GxP in skladnost z Novartisovimi sistemi vodenja kakovosti.**About the Role**:Major Accountabilities~ Nadzor nad vsemi proizvodnimi in testnimi aktivnostmi, zagotavlja skladnost s cGxP, vključno s celovitostjo podatkov in...

  • QA Deviations Specialist

    hace 3 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**:~Verwaltet Qualitätsaspekte und Projekte im Verantwortungsbereich.~Gewährleistet und unterstützt die GxP-Konformität und die Einhaltung der Qualitätsmanagementsysteme von Novartis.**About the Role**:Major Accountabilities~ Überwachung aller Produktions- und Testaktivitäten, Sicherstellung der Einhaltung von cGxP, inkl. Datenintegrität und...

  • QA Deviations Specialist

    hace 3 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**:~Beheert kwaliteitsaspecten en projecten binnen het verantwoordelijkheidsgebied.~Garandeert en ondersteunt de algehele GxP-conformiteit en naleving van de Novartis-kwaliteitsmanagementsystemen.**About the Role**:Major Accountabilities~ Toezicht op alle productie- en testactiviteiten, zorgt voor naleving van cGxP, inclusief gegevensintegriteit en...

  • QA Deviations Specialist

    hace 3 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**:~責任範囲内で品質面とプロジェクトを管理します。~全体的なGxP適合性とノバルティス品質管理システムへの準拠を保証およびサポートします。**About the Role**:Major Accountabilities~

  • QA Deviations Specialist

    hace 3 días

    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...

  • QA Deviations Specialist

    hace 3 días

    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,...

  • Specialist, Manufacturing Technical Support

    hace 1 semana

    Insurgentes, México Novartis A tiempo completo

    **Summary**: Job Description Summary The Specialist, Manufacturing Technical Support, provides expert support for all process-specific issues to manufacturing, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to GMPs, SOPs and applicable guidelines and functional standards. **About the...

  • Specialist, Manufacturing Technical Support

    hace 6 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**: The Specialist, Manufacturing Technical Support, provides expert support for all process-specific issues to manufacturing, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards. **About the Role**:...