Ignacio Puebla

Head of Quality (QA/QC/RA Director) & Qualified Person at Unolab manufacturing S.L
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Contact Information
us****@****om
(386) 825-5501
Location
ES
Languages
  • Spanish Native or bilingual proficiency
  • English Full professional proficiency
Skills

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Guillermo Cleti

Oscar Ignacio, es un profesional muy competente, altamente capacitado tanto en GMP, como en manejo de personal. Ha demostrado compromiso, con aquellas instituciones por donde ha desarrollado su actividad profesional. Posee aptitudes para el trabajo en equipo, ejercicio pleno de la función gerencial, toma de decisiones, manejo del riesgo, liderazgo de la gente que conduce y actitud propositiva.

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Credentials

  • Lean Six Sigma Black Belt
    Aveta Business Institute
    Jan, 2015
    - Nov, 2024
  • First Certificate in English (FCE)
    University of Cambridge
    Dec, 2003
    - Nov, 2024

Experience

  • Unolab Manufacturing
    • Spain
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Head of Quality (QA/QC/RA Director) & Qualified Person
      • Mar 2019 - Present

      CMO specialized in sterile products manufactured by aseptic processing using BFS (Blow-Fill-Seal) technology.Key Achievements: Frontline person in more than 60 successful audits (Scope EU GMP, ISO13845 / 2016 – 2020 period) Process Owner of the successful qualification and start-up of one serialization & aggregation line in compliance to Falsified Medicine Directive (FMD). 2019 Process Owner of the successful qualification and regulatory approval (ISO 13485) of a new production line involving major changes in the Clean Steam System, new cleanrooms (ISO 7 & ISO 8) and BFS equipment. 2018 Process Owner of the successful qualification and regulatory approval (EU GMP & ISO 13485) of a new production line involving major changes in the Purified Water System, new cleanrooms (ISO 7 / Grade C and ISO (/ grade D) and BFS equipment. 2015 Show less

    • Head of Quality (QA/QC Director)
      • Jul 2016 - Mar 2019

      CMO especializada en productos estériles por procesamiento aséptico utilizando tecnología BFS (Blow-Fill-Seal).

    • Quality Assurance Manager
      • Jan 2015 - Jun 2016

      CMO especializada en productos estériles por procesamiento aséptico utilizando tecnología BFS (Blow-Fill-Seal).

  • LEM S.E
    • Argentina
    • Plant Manager - Qualified Person
      • Jun 2011 - Jul 2014

      Planta de Producción de Soluciones Parenterales de 100 ml a 500 ml. Principales logros: * Reestructuración completa del Sistema de Calidad y de todas las áreas de la Planta de Soluciones Parenterales: Control de Calidad, Garantía de Calidad, Producción, Mantenimiento y Depósitos. * Planeamiento e implementación del Sistema de Control de Cambios y del Sistema de Desvíos. * Liderazgo a través del ejemplo de un grupo de trabajo de 35 personas. * 25% de aumento en las unidades manufacturadas (junio 2011-diciembre 2011) con el mismo personal. * 67% de aumento en las unidades manufacturadas (2011-2013). Show less

  • LABORATORIO LANDI / LABORATORIOS POLYBIUS S.A
    • Quality Assurance Manager - Qualified Person - Plant Manager
      • Sep 1999 - May 2011

      Large Volume Parenteral (LVP) production site.

    • Quality Control Manager - Technical Director
      • Jun 1997 - Aug 1999

      Large Volume Parenteral (LVP) production site.

  • Cátedra de Química Analítica de Medicamentos - Facultad de Cs. Bioq. y Farmacéuticas - UNR
    • Argentina
    • Laboratory Assistant
      • Nov 1996 - Apr 1998

  • Farmacia Ghezzi
    • Rosario, Argentina
    • Co-Technical Director
      • Mar 1995 - May 1997

Education

  • EUDE Business School
    Master of Business Administration (MBA), Máster en Administración y Dirección de Empresas
    2016 - 2017
  • Universitat de Barcelona
    Specialist. Quality Systems in Research and Pharmaceutical Industry
    2014 - 2015
  • Ministerio de Educación de España
    Pharmacist, Pharmacy
  • Facultad de Ciencias Bioquimicas y Farmaceuticas, Universidad Nacional de Rosario
    Pharmacist, Pharmacy
    1990 - 1995

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