Sara Bobbio

QC Specialist, AS&T Coordinator and QC Supervisor at Micro-Sphere SA
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Contact Information
us****@****om
(386) 825-5501
Location
Ponte Tresa, Ticino, Switzerland, CH
Languages
  • Inglese -
Skills

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Credentials

  • Project Management Foundations: Quality
    LinkedIn
    Mar, 2020
    - Nov, 2024

Experience

  • Micro-Sphere SA
    • Switzerland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QC Specialist, AS&T Coordinator and QC Supervisor
      • Jul 2023 - Present

      •Handling and writing of Quality Event like DEV, AD, OOS, OOE\OOT •Writing/Review process of Analytical method validation/transfer documents (protocol/report) and excel sheet validation documentation•Lifecycle review of analytical methods•QC key reference for the implementation and management of new projects•Reference person for technical-related matters for customers and suppliers •Trains and supervised the work of new QC employees •Partecipates as QC-SME to internal and third-party audits•Active support for quality improvements•Review Chemical / HPLC / GC analysis •Review of analytical documentation for raw material and API release.•Review and writing SOPs.•Review following the main guidelines such as ICH and pharmacopeias.•Manage and organization of AS&T group’s and third-party laboratory activities.•Basis of project management Show less

    • Analytical Science & Tecnology Coordinator and QC Supervisor
      • Sep 2021 - Jul 2023

      •Writing/Review process of Analytical method validation/transfer documents (protocol/report) and excel sheet validation documentation•Lifecycle review of analytical methods•QC key reference for the implementation and management of new projects•Reference person for technical-related matters for customers and suppliers •Trains and supervised the work of new QC employees •Partecipates as QC-SME to internal and third-party audits•Active support for quality improvements•Review Chemical / HPLC / GC analysis •Review of analytical documentation for raw material and API release.•Review and writing SOPs.•Review following the main guidelines such as ICH and pharmacopeias.•Manage and organization of AS&T group’s and third-party laboratory activities.•Basis of project management Show less

  • Novartis
    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Lab Analyst (QC)
      • Nov 2013 - Oct 2021

      • Chemical / HPLC / GC / HPLC-MS analysis for stability studies, method registration and release of inhaler products following prescriptions or pharmacopeias • Independent execution of routine analysis • Sample Preparation with special techniques such as Andersen Cascade Impactor (ACI), New Generation Impactor (NGI), Uniformity of Delivered Dose (EDU) • Sample Preparation for assay by HPLC/GC/HPLC-MS and degradation products by HPLC • Sample visual examination • Physical testing • Analysis review • Writing of test documentation in accordance with cGMP guidelines • Evaluation of raw data and Recording of analysis results in SAP • Opening of OOS/OOE/Deviation report • Basis of reference management with SAP • Planned maintenance of the main HPLC brands e type, such as Agilent system, Shimadzu and thermo system. Show less

Education

  • ITI S L. Cobianchi
    Diploma di perito chimico industriale, Chimica industriale
    2008 - 2013

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