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Experience

    • QA SPECIALIST
      • Oct 2011 - Present

      A contract manufacturer of prescription and over-the-counter (OTC) pharmaceutical products as well as cosmetics.; Batch record review, internal auditor, SOP writer, APR reporting

    • MANAGER, COMPLIANCE AND REGULATORY AFFAIRS
      • Jul 2008 - Jun 2011

      is the market leader in heat-sealable films for packaging individual portions, for the food, pharmaceutical and healthcare industry.MANAGER, COMPLIANCE AND REGULATORY AFFAIRSHACCP standard trainingCertified SQF PractitionerDMF Holder (packaging components)Introduced and revised SOPsCustomer complaint investigator

    • QA SPECIALIST
      • Jan 1989 - Jan 2007

      , a subcontract manufacturer of pharmaceutical products in a wide variety of dosages and forms.; Review and approval of documentation for manufacturing, packaging for Tablets, Creams and Ointments, Sterile Products and Lyophilized Products, according to GMP and FDA regulations.CAPA specialist and product complaint investigatorIntroduced training procedure to certify all new QA specialists Collaborated with the implementation of the SAP System (ERP / 3).Introduced and revised SOP'sCoordinator for the continuous improvement program (J.C. Savard Consultants).

    • Packaging component Inspector
      • Mar 1982 - Jun 1989

      Sampling, inspecting and approving all packaging components. • Reviewed all procedures for the inspection of packaging items for tablets, sterile products and creams and ointments. • Initiated and introduced levels of classification of defects (minor, major and critical) of packaging items, in collaboration with the engineering department.

    • Laboratory Technician
      • Jun 1981 - Nov 1981

      Perform laboratory analysis: pH, extraction, assay

Education

  • 1990 - 1999
    HEC Montréal
    BsC., Gestion des opérations, informatique, qualité
  • Dawson College
    Chemical Technology Diploma (D.E.C
  • 1972 - 1977
    Laval Catholic High School
    High School Certificate

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Industry Focus. “Pharmaceutical Manufacturing”

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