Agata Ochocinska

Head of Quality & Regulatory Europe, Actylis at Actylis
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Lyon Area, FR

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Experience

    • United States
    • Chemical Raw Materials Manufacturing
    • 100 - 200 Employee
    • Head of Quality & Regulatory Europe, Actylis
      • Sep 2022 - Present

      Heading an international team of Quality and Regulatory experts supporting Actylis LifeScience organisation in API/ EXP, Cosmetics, Nutrition, PI and SC business units.

    • Senior Manager Quality
      • May 2022 - Sep 2022

      Quality Team manager dealing with QA QC aspects for chemicals destined for speciality chemicals businesses as well as pharma, nutrition and cosmetic areas.

    • Biotechnology Research
    • 700 & Above Employee
    • Quality Manager Sigma Aldrich France
      • Oct 2018 - May 2022

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Quality Assurance Engineer
      • Oct 2015 - Sep 2018

      - Quality Assurance in API's manufacturing (GMP/ ICH Q7) - Change Control/ Deviation/ OOS - New Process Validation/ complementary validation - raw materials qualification - new Process implementation : portfolio follow up/ Operational Risk Analysis/ set-up optimisation - Project Management (new process evaluation/ feasibility studies/ quotations/ contribution to final offer proposal) - SAP Key User - Managing a portfolio of products (customer communication, process implementation and validation, routine manuifacturing follow up, etc.) - Communication with customers/ Suppliers both international - Direct management Show less

  • BASF Pharma Saint-Vulbas
    • Saint-Vulbas, France
    • Quality Assurance Engineer
      • Dec 2014 - Oct 2015

      - Quality Assurance in API's manufacturing (GMP/ ICH Q7) - Change Control/ Deviation/ OOS - Product Batch Validation process follow-up - Managing a portfolio of products - Communication with customers/ Suppliers - Quality Assurance in API's manufacturing (GMP/ ICH Q7) - Change Control/ Deviation/ OOS - Product Batch Validation process follow-up - Managing a portfolio of products - Communication with customers/ Suppliers

    • Germany
    • Chemical Manufacturing
    • 700 & Above Employee
    • Site Quality Manager Intern
      • Feb 2014 - Aug 2014

      - ISO/TS 16949 and its requirements; analys- Quality Management System analysis; process optimisation; process troubleshooting and follow-up ; - internal audits - process audits (5M); -Risk Assessment Tools (FMEA, FTA) and fault analysis tools (ex. 8D, 5M) - initiating the Site Risk Landscape (in preparation for ISO 9001 v 2015) - update of process FMEA and related documentation (Monitoring Plans) - ISO 31000 (and 31004); ISO 19011; ISO 14001 - ISO/TS 16949 and its requirements; analys- Quality Management System analysis; process optimisation; process troubleshooting and follow-up ; - internal audits - process audits (5M); -Risk Assessment Tools (FMEA, FTA) and fault analysis tools (ex. 8D, 5M) - initiating the Site Risk Landscape (in preparation for ISO 9001 v 2015) - update of process FMEA and related documentation (Monitoring Plans) - ISO 31000 (and 31004); ISO 19011; ISO 14001

    • Consultant
      • Sep 2011 - Oct 2011

      Consultant, organic synthetic chemistry;

    • Consultant
      • Sep 2011 - Oct 2011

      I solved a synthetic problem blocking production of multiple key molecules.

    • Sweden
    • Higher Education
    • 700 & Above Employee
    • Post-Doc
      • Oct 2009 - Apr 2011

    • United Kingdom
    • Higher Education
    • 700 & Above Employee
    • PhD
      • 2005 - 2010

Education

  • Université de Technologie de Compiègne, Compiègne
    Master's degree, Qualité et Performance dans les organisations/Quality and Performance
    2013 - 2014
  • The University of Reading
    Ph.D., Organic Chemistry
    2005 - 2010
  • Uniwersytet im. Adama Mickiewicza w Poznaniu
    Masters, Chemistry
    2000 - 2005

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