Andreas Gkikas

Andreas Gkikas

Quality Control Analyst

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  • Timeline

  • About me

    Regulatory Affairs Officer at Genepharm S.A.

  • Education

    • University of Ioannina

      2008 - 2014
      Bachelor's degree Chemistry
    • University of Ioannina

      2014 - 2017
      Master of Science - MSc Inorganic Chemistry 9.73

      Diploma thesis title : "Synthesis and characterization of Ruthenium (II) complexes with modified terpyridines"

  • Experience

    • RAFARM S.A

      Jun 2018 - Dec 2019
      Quality Control Analyst

      Quality Control Analyst- UV, HPLC analysis of finished products- Water & Clean Steam sampling and analysis (Participation in Process Qualification) - In Process Controls

    • KLEVA Pharmaceuticals S.A.

      Jan 2020 - Mar 2022
      Research And Development Analyst

      Analytical R&D scientist- Development and Validation of Analytical Methods- Registration of Analytical Methods, Reports & Protocols

    • Genepharm SA

      Mar 2022 - now

      Gather information and documentation for variation applications. Responsible for module 3 and section 2.3 of the dossier. Preparation of variation package and responses to authorities. I ensure compliance with European as well as regional legislation and guidelines.

      • Regulatory Affairs Officer

        Nov 2024 - now
      • Regulatory Affairs Officer (Post-approval procedures)

        Mar 2022 - Nov 2024
  • Licenses & Certifications

    • Cosmetics: From Regulatory to Cosmetovigilance

      Panhellenic Association of Pharmacists
      Jul 2023
    • Dissolution Method Validation Mastery

      Udemy
      Mar 2021
    • Assay Method Validation Mastery

      Udemy
      May 2021
    • Marketing and Brand

      National & Kapodistrian University of Athens
      Jul 2019
    • The Production of Pharmaceutical and Parapharmaceutical Products

      National & Kapodistrian University of Athens
      May 2019
    • Dissolution Seminar Series

      Agilent Technologies
      Jul 2020
    • Validation/Verification of Analytical Methods

      Association of Greek Chemists
      Feb 2021