Luca Biondini

Analytical Laboratory Technician at Cerbios-Pharma SA
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Contact Information
us****@****om
(386) 825-5501
Location
CH
Languages
  • Italian Native or bilingual proficiency
  • French Full professional proficiency
  • German Full professional proficiency
  • English Professional working proficiency

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Credentials

  • Understanding TACCP and VACCP
    Train4Academy Ltd
    Mar, 2023
    - Nov, 2024
  • Food and Beverage Management
    Coursera
    Feb, 2021
    - Nov, 2024
  • Course Certification for ISO 22000:2018 Food Safety management System (FSMS)
    Udemy
    Jan, 2021
    - Nov, 2024
  • Attendance for introduction to the Risk Based Thinking (ISO 31000)
    DNV GL Training
    Dec, 2020
    - Nov, 2024
  • Course certification for ISO 90001:2015
    Udemy
    Dec, 2020
    - Nov, 2024
  • Consultant of the HACCP Procedures
    Anfos Servizi Srl
    Sep, 2020
    - Nov, 2024
  • Consultant of the HACCP Procedures: training for SARS CoV-2 health emergency
    Anfos Servizi Srl
    Sep, 2020
    - Nov, 2024
  • HACCP Training Course Risk Level 3
    Anfos Servizi Srl
    Aug, 2020
    - Nov, 2024
  • " ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories - Manage change". Training Course
    AISF - Associazione Italiana Software & Formazione
    Jun, 2020
    - Nov, 2024
  • Chemical Risk
    AITI - Associazione industrie ticinesi
    Feb, 2018
    - Nov, 2024
  • Training Certificate for HPLC Infinity II and OpenLab Chemstation
    Agilent Technologies
    Feb, 2017
    - Nov, 2024
  • Training for HPLC HITACHI-Merck and System Manager
    VWR, part of Avantor
    Dec, 2016
    - Nov, 2024
  • HACCP Training Certificate for Food Operators
    Pedago.it
    May, 2020
    - Nov, 2024

Experience

  • Cerbios-Pharma SA
    • Switzerland
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Analytical Laboratory Technician
      • Nov 2018 - Present

      Work in the Chemical Analysis Laboratory of the Quality Control Department. Excellent knowledge of analytical techniques (HPLC, GC, UV-VIS, IR, TOC, Titration, Polarimetry, ...) Knowledge of chemical and physical analytical methods. Knowledge of cGMP and ICH guidelines. Handling and analyses of starting materials, bulk products, finished products, stability products. Sampling of raw materials and packaging materials. Handling of HPAPIs according to HSE procedures. Review of analitical raw data. Show less

  • LAGAP SA
    • Switzerland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Laboratory Manager
      • Oct 2016 - Oct 2018

      Responsibility: Planning and feasibility of projects related to pharmaceutical forms. Analytical methods development. Validation of analytical methods according to Pharmacopoeias, cGMPs, ICH Q2 (R1) and internal SOP's. Preparation and revision of SOP’s. Use of HPLC and various instruments inherent in all analyses required. Contacts with suppliers, instrument technicians, instrumentation support companies. Contacts with external laboratories and companies in synergy with the QA / QP Quarterly, half-yearly or annual checks in relation to internal requirements relating to laboratory instruments. Standard purchase management, consumer products, laboratory-related tools. Management of the analytical requests with the Quality Control of Lagap SA. Respond to regulatory requests. Preparation of stability protocols and drafting of stability reports. Timing management in the execution of laboratory analyses Programming of analytical activities during the Process Validation Analytical transfers: drafting of protocols and reports, analytical execution Management of out of specification (OOS) data and deviations; classification of the analytical deviations. Preparation of the laboratory for the Self-inspection and cGMP inspections. Skills: Ability to manage a series of projects and initiatives simultaneously. Effective ability to manage the requests for both of chemical-physical and microbiological analyses. Show less

  • IBSA Farmaceutici
    • Italy
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Analytical Laboratory Senior Technician
      • Apr 2007 - Sep 2016

      Work in the Chemical Analysis Laboratory of the Quality Control Department. Experience and mastery in physical and chemical analysis techniques: -HPLC-UV / -RI / -DAD -DI / HS-GC-FID -UV-VIS -FT-IR -NIR -Titrino -Hardness test Use of various chemical and physical instruments: TLC, KF, Polarimetry, Texture test, Dissolution test, Disintegration test, Optical microscope, Digital density meter. Analysis of: raw materials, finished products, bulk products, holding time products and packaging materials. Analysis of cleaning validation samples. Preparation of analysis methods and specifications according to USP and Ph. Eur. Drafting of analysis sheets. Management and purchase of glassware and laboratory reagents. Verification of good functionality of laboratory equipments. Participation in Swissmedic and FDA inspections Show less

Education

  • Università degli Studi di Milano
    Master's degree, Pharmaceutical Chemistry and Technology (C.T.F.)
    1998 - 2006
  • Collegio Papio
    Federal diploma, Literary high school
    1994 - 1998

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