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Luisanna Zedda

Luisanna Zedda

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location of Luisanna ZeddaSiena, Tuscany, Italy

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  • Timeline

  • About me

    QA Release, Trending and Compliance Manager

  • Education

    • Universidad de Santiago de Compostela

      1999 - 2000

      ERASMUS program

    • Università degli Studi di Siena

      2002 - 2003
      Master on Drug Design and Synthesis

      Activities and Societies: 10-month stage performed in Novartis V&D – Siena, Technical Development Department Teaching Modules:• Medicinal Chemistry• Drug Design and Drug Optimization• Analytical Problems in Medicinal Chemistry

    • Università degli Studi di Siena

      2003 - 2006
      PhD on Biomedicine and Immunological Science School of Medicine

      PhD project: “Identification of Chlamydia trachomatis proteins as possible vaccine candidates”. Study of strategies for an anti-Chlamydia Vaccine Development carried out on Biochemistry and Molecular Biology Department in Novartis V&D – Siena.

    • Università degli Studi di Cagliari

      1995 - 2002
      Chemistry and Pharmaceutical Technologies Chemistry 110/110 cum laude

      Thesis on "Synthesis and study of new products with thyazolic structure"

  • Experience

    • GSK

      Jan 2015 - now

      Accountable for Aseptic Batch release, Quality KPIs monitoring and inspections Readiness Sustain Site Data Integrity GovernanceLead projects related to Data Integrity Journey Sustain the Site Data Integrity ProgramManagement of product specific projectsManagement of Site Quality Plan Analysis of the Immunological response to vaccine candidates in clinical trial samples. Particular focus to the analysis of the frequency and functionality of antigen-specific T cells in response to vaccination. Set-up, standardization and prioritization of immunological assays to analyze antigen-specific T cells in response tailored for the different clinical studies (eg: multiparametric FACS analysis, proliferation, multiplex analysis of cytokine content in plasma). Contribute in building and sustaining governance, processes, structure and infrastructure in a Cross-functional production Team.

      • Release, Trending and Compliance Manager in QA Aseptic Operations Unit

        Apr 2022 - now

      • Data Integrity Lead

        Nov 2016 - Mar 2022

      • QA Project Manager

        Apr 2016 - Oct 2016

      • Research Center_Translational Medicine_Post doc

        Jan 2007 - Mar 2016

      • Project Manager (job rotation program)

        Jan 2015 - Dec 2015

  • Licenses & Certifications

    • Clinical Research Training for Junior CRAs by ECCRT (European Centre for Clinical Research Training)