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Sandra Nedog

Sandra Nedog

Summer student internship in Regulatory affairs

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location of Sandra NedogSlovenia

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  • Timeline

  • About me

    Young leader in Quality

  • Education

    • University of Ljubljana, Faculty of Pharmacy

      2009 - 2014
      Master's Degree Pharmacy

      Activities and Societies: Student Association Uniform master's study programme includes 59 units - 56 subjects, traineeship in educational institutions which are public, private or hospital pharmacy, individual research work for the master's thesis and master's thesis defence.Among 56 subjects there are 30 compulsory, subdived into basic and professional subjects, and 26 selective subjects. Compulsory subjects include basic knowledge of natural science (mathematics, physics, general, inorganic, organic, analytical… Show more Uniform master's study programme includes 59 units - 56 subjects, traineeship in educational institutions which are public, private or hospital pharmacy, individual research work for the master's thesis and master's thesis defence.Among 56 subjects there are 30 compulsory, subdived into basic and professional subjects, and 26 selective subjects. Compulsory subjects include basic knowledge of natural science (mathematics, physics, general, inorganic, organic, analytical chemistry, and physical chemistry) and medical subjects (anatomy and histology, physiology, pathological physiology, microbiology and pharmacology).Compulsory professional subjects provide students with the basic professional and in-depth scientific knowledge of Pharmacy, taking into account its highly interdisciplinary orientation. Show less

    • Gymnasium Vič

      2006 - 2009
      HIigh School Graduate HIGH SCHOOL/SECONDARY DIPLOMAS AND CERTIFICATES

  • Experience

    • Lek Pharmaceuticals

      Aug 2011 - Sept 2011
      Summer student internship in Regulatory affairs

      Supported work in Regulatory Competence Center by collecting information from countries of specific requirements for registration process (EU and non-EU countries).

    • The European Association of Hospital Pharmacists (EAHP)

      Oct 2014 - Sept 2015
      Intern at the headquaters of the professional non-government association

      Activities and responsibilites:- preparing scientific articles, - investigating the issue of drug shortages,- preparing responses on public consultations from EMA and EU, - successfully filling the EU grant application, - leading EAHP Hospital Pharmacy Internship Programme,- supporting the preparation of the professional congress,- participating in events hosted in EU parliament.

    • Novartis

      Oct 2015 - Jul 2023

      The Novartis Talent Excellence Program called STEP is an accelerated, two-year leadership development program, that builds strong cross-functional knowledge in Quality Assurance, Production and Development.Assignment in Global Quality Strategic Planning (Apr - Sep 2017)- business Intelligence: visualizing big data- organizing management governance meetings- PMO for Regulatory - Quality Governance BoardAssignment in Manufacturing Science & Technology Sandoz Boucherville, Canada (Jul 2016 - Mar 2017)- worked as Product Steward (technical transfers)- lead Quality Risk Management (QRM) and changes of legacy products- driven implementation of new QRM tool,- supported IQP project "Reduction of scrap rate on aseptic filling line"Assignment in Quality Unit at Sandoz Unterach (Oct 2015 - June 2016)- lead IQP Lean and Six Sigma Green Belt Project,- supported and/or led Quality Improvement projects, - performed complaint investigations,- supported ad hoc activities in Quality Unit (e.g. supported on-site inspections), - participated at the on-site meetings and activities (e.g. GMP walkthroughs, Self-Inspections). Show less

      • Global Head QMS Governance

        Sept 2022 - Jul 2023

      • Global QMS Manager

        Mar 2019 - Aug 2022

      • Global QA Process Manager

        Sept 2017 - Mar 2019

      • Global Quality and MS&T Graduate Trainee

        Oct 2015 - Sept 2017

    • Sandoz

      Aug 2023 - now
      Global Development QA Biosimilar Project Lead

      Responsible QA manager for assigned development Biosimilar Project developed at CDMOs

  • Licenses & Certifications

    • Getting Things Done

      LinkedIn
      Dec 2020
      View certificate certificate

    • Cambridge ESOL Level 1 Certificate in ESOL International

      University of Cambridge

  • Volunteer Experience

    • Vice President of Education

      Issued by European Pharmaceutical Students' Association on Jun 2014
      European Pharmaceutical Students' AssociationAssociated with Sandra Nedog

    • Training Coordinator

      Issued by European Pharmaceutical Students' Association on Apr 2012
      European Pharmaceutical Students' AssociationAssociated with Sandra Nedog

    • EPSA Liaison Secretary

      Issued by Društvo Študentov Farmacije Slovenija on Apr 2011
      Društvo Študentov Farmacije SlovenijaAssociated with Sandra Nedog