Claribeth Arias Gutierrez

Advanced Therapy Researcher - Quality Assurance Professional at Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS
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Contact Information
us****@****om
(386) 825-5501
Location
Bogota, D.C., Capital District, Colombia, CO

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Andrés F. Torres G, Pharm.B, M.S(c)

Claribeth es una excelente profesional farmaceútica con marcada experticia en Aseguramiento de la Calidad Farmacéutica, Conducción y Monitoreo de Ensayos Clínicos y Regulación de Terapias Avanzadas. Una profesional proactiva, servicial y orientada al logro.

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Experience

    • Colombia
    • Wellness and Fitness Services
    • 1 - 100 Employee
    • Advanced Therapy Researcher - Quality Assurance Professional
      • Jun 2022 - Present

      • Drafted documentation for implementing Good Manufacturing Practices and Good Clinical Practices for Advanced Therapies (Gene Therapy, Cellular and Tissue) based on EMA-FDA-ANVISA regulations. • Provided support in designing research protocols, standard operating procedures, informed consent, and investigator manuals. • Conducted training in Good Documentation Practices and cleaning procedures for white areas of biopharmaceutical production. • Drafted documentation for designing clinical trials. Show less

    • Colombia
    • Wholesale Drugs and Sundries
    • 1 - 100 Employee
    • Pharmacy Technical Director
      • Jan 2022 - Mar 2022

      • Directed and coordinated the pharmaceutical service, including conducting pharmacotherapeutic follow-up for polymedicated patients and managing the custody of special control and state monopoly drugs. • Attended visits by control entities. • Directed the Pharmacy and Therapeutics Committee. • Directed and coordinated the pharmaceutical service, including conducting pharmacotherapeutic follow-up for polymedicated patients and managing the custody of special control and state monopoly drugs. • Attended visits by control entities. • Directed the Pharmacy and Therapeutics Committee.

    • Colombia
    • Research Services
    • 100 - 200 Employee
    • Clinical Research Pharmaceutical Chemist
      • Jul 2021 - Oct 2021

      • Enabled Pharmaceutical Services for the appropriate conduction of Clinical Trials. • Conducted reconstitution and blinding of vaccines under study. • Coordinated the Pharmaceutical Service. • Directed the Pharmacy and Therapeutics Committee of both offices. • Enabled Pharmaceutical Services for the appropriate conduction of Clinical Trials. • Conducted reconstitution and blinding of vaccines under study. • Coordinated the Pharmaceutical Service. • Directed the Pharmacy and Therapeutics Committee of both offices.

  • Exsal Soluciones SAS
    • Envigado, Antioquia, Colombia
    • Pharmaceutical Establishment Technical Director
      • Feb 2021 - Jun 2021

      • Obtained the favorable sanitary concept for the pharmaceutical establishment. • Wrote the documentation system to comply with current technical and legal requirements. • Obtained the favorable sanitary concept for the pharmaceutical establishment. • Wrote the documentation system to comply with current technical and legal requirements.

    • Canada
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Intern
      • Jul 2020 - Jan 2021

      Provided support in implementing the EU-GMP standard (Good Manufacturing Practices - European Union). Administered the Document Management System Provided support in implementing the EU-GMP standard (Good Manufacturing Practices - European Union). Administered the Document Management System

Education

  • UNICLA
    Doctorate in Public Health (Ph.D/Dr.PH)
    2023 -
  • Fundación Universitaria de Ciencias de la Salud
    Master in Bioengineering and Nanotechnology (M.Sc), Terapias Avanzadas
    2021 - 2023
  • Universidad CES
    Pharmaceutical Chemist
    2015 - 2020

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