Elena González Rodríguez

Quality Manager at INSULCLOUD 360º
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Contact Information
us****@****om
(386) 825-5501
Location
Spain, ES
Languages
  • Inglés Full professional proficiency

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Celia Vazquez Lopez

Después de casi 20 años en la industria, liderando proyectos muy importantes... pasando 6 auditorias FDA, ANVISA, JAPON, auditando por medio mundo.. uno de los que considero mis mayores logros profesionales y el que mas me llena de orgullo, es de haberte seleccionado, y de haber participado en tu formación, de ayudarte a crecer profesional y personalmente y ver en lo que te has convertido. Conseguirás todo lo que te propongas. Ya no te hace falta mucho mas, sobre todo... no cambies jamas.

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Credentials

  • Certificate in Advanced English
    Cambridge Assessment
    Mar, 2019
    - Oct, 2024
  • First Certificate in English (FCE), B2 Level
    Cambridge English Language Assessment
    Dec, 2015
    - Oct, 2024

Experience

  • INSULCLOUD 360º
    • Spain
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Quality Manager
      • Jul 2022 - Present

      ISO 13485 certification: design and implementation of the QMS in the organization according to ISO 13485, MDR and 21 CFR 820. Project management and supervision of personnel in charge. Coordination with the Technical Manager in the definition of the appropriate resources to ensure the quality of the products (Hardware and Software) and to establish continuous improvement processes. Project coordination to obtain FDA clearance. ISO 13485 certification: design and implementation of the QMS in the organization according to ISO 13485, MDR and 21 CFR 820. Project management and supervision of personnel in charge. Coordination with the Technical Manager in the definition of the appropriate resources to ensure the quality of the products (Hardware and Software) and to establish continuous improvement processes. Project coordination to obtain FDA clearance.

  • Meiji Pharma Spain, S.A.
    • Spain
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Quality Assurance Technician. Suppliers
      • Oct 2021 - Jul 2022

      Supervision and collaboration in the approval of suppliers and in their follow-up once approved, coordinating relations with them, and managing any incidents that may arise from the quality point of view.Cooperation in the tasks involved in the implementation and monitoring of a QMS for medicines and medical devices, including sterile products.Internal and external audits. Support in customer audits and official inspections (AEMPS, ISO 13485, FDA, ANVISA, etc.).

    • Quality Assurance Technician. New projects
      • Jul 2017 - Nov 2021

      Collaboration in international relations with Japanese (drug) and American (medical device) customers, preparing and managing the documentation involved.Creation and collaboration in the implementation of the company's business continuity plan.Cooperation in the tasks involved in the implementation and monitoring of a QMS for medicines and medical devices, including sterile products.Internal and external audits. Support in customer audits and official inspections (AEMPS, ISO 13485, FDA, ANVISA, etc.).Management of the interdepartmental relationship with Pharmacovigilance and R&D. Show less

    • Quality Control Technician
      • May 2017 - Jul 2017

      Preparation of laboratory reports, SOPs, SAP analysis bulletins, specifications, investigations and sampling instructions and test methods according to Japanese, European and American Pharmacopoeia.

  • GES GENERICOS LABORATORIO S.A./GENFARMA S.L/ BIOMENDI S.A.
    • Validation Technician
      • Feb 2017 - May 2017

      Preparation of documentation for the validation system: protocols and reports for process validations, cleaning validations and equipment qualifications. Use of risk analysis to document validation reports and protocols. Annual follow-up of calibrations, qualifications and validations of equipment and instruments working with different external suppliers. Preparation of deviations and associated CAPAs of the validation system. Preparation of documentation for the validation system: protocols and reports for process validations, cleaning validations and equipment qualifications. Use of risk analysis to document validation reports and protocols. Annual follow-up of calibrations, qualifications and validations of equipment and instruments working with different external suppliers. Preparation of deviations and associated CAPAs of the validation system.

  • Tedec- Meiji Farma, S.A.
    • Logistics Technician
      • Jan 2017 - Feb 2017

      Issuance and closing of manufacturing orders and manufacturing documentation.Management of batches traceability in SAP.

    • Quality Assurance Technician
      • Apr 2016 - Jan 2017

      Cooperation in the tasks involved in the implementation and monitoring of a quality assurance system based on GMP, FDA and medical device standards (MDD and 21 CFR 820).Preparation and updating of SOPs, change controls, non-conformities, deviations, OOS, CAPAs, KPIs, RPAs, risk analysis, audits, preparation of protocols and reports (stability, cleaning validation and manufacturing validation).

  • Lancaster Gate Hotel
    • United Kingdom
    • Hospitality
    • 1 - 100 Employee
    • Breakfast Supervisor
      • Jan 2015 - Jun 2015

      Responsible for food and beverage, operational and bar staff. Responsible for food and beverage, operational and bar staff.

  • Universidad Pontificia Comillas ICAI-ICADE
    • Externships
      • Sep 2013 - Dec 2013

      Obtaining graphene by chemical exfoliation for applications in nanomaterials. Obtaining graphene by chemical exfoliation for applications in nanomaterials.

Education

  • Talento-EPHOS
    Máster en Farmacia industrial y registro de medicamentos
    2016 - 2017
  • British Council
    Business Communication Skills Course
    2016 - 2016
  • Universidad Autónoma de Madrid
    Grado en Química
    2009 - 2014
  • Colegio Maristas Chamberí
    E.S.O y Bachillerato

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