Mélanie Litzler

Regulatory Affairs Associate & Deputy local QPPV at Merz Pharma (Schweiz) AG
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Mulhouse Area, FR

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Experience

    • Switzerland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Associate & Deputy local QPPV
      • Jun 2011 - Present

      Responsible for the life cycle management and regulatory issues for medicinal products, medical devices, food supplements and cosmetics. Co-responsible for the close cooperation with the responsible product managers, participation in projects and product team meetings. Shared responsibility for the processing and forwarding of adverse events to the respective contractual partners in accordance with the respective SDEA and to authorities; independent follow-ups upon receipt of safety-related signals. Show less

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Training Period of BTEC Higher National Diploma in Biochemistry
      • Jun 2007 - Present

      Is the medicinal product X responsible for adverse events ? Extraction of RNA, inverse transcriptase, PCR in real in genes of interest. Is the medicinal product X responsible for adverse events ? Extraction of RNA, inverse transcriptase, PCR in real in genes of interest.

    • Netherlands
    • Chemical Manufacturing
    • 700 & Above Employee
    • Laboratory Technician
      • Oct 2008 - Jan 2009

      Determination of amino acids by the method of high performance liquid chromatography. Ensure the maintenance of equipements. Apply the Good Laboratory Practices. Manage the organisation of the laboratory and the stock of consumables. Determination of amino acids by the method of high performance liquid chromatography. Ensure the maintenance of equipements. Apply the Good Laboratory Practices. Manage the organisation of the laboratory and the stock of consumables.

    • France
    • Research Services
    • 1 - 100 Employee
    • Training Period of BTEC Higher National Diploma in Biochemistry
      • Dec 2007 - Oct 2008

      Determination of the presence of nitrites and lactic acid to be able to determine the influence on Listeria monocytogenes by meat products. Determination of the presence of nitrites and lactic acid to be able to determine the influence on Listeria monocytogenes by meat products.

  • Lycée Jean Rostand Strasbourg
    • Straßburg, Großer Osten, Frankreich
    • BTEC Higher National Diploma in Biochemistry
      • Sep 2006 - Sep 2008

    • France
    • Food Production
    • 1 - 100 Employee
    • 1st year of BTEC in food Industr
      • Sep 2005 - Sep 2006

    • Bachelor of Sciences & technology of Laboratory
      • Sep 2002 - Sep 2005

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