Experience

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  Sterinova

  • Saint-Hyacinthe, Québec, Canada

  • Validation Specialist

    • Sep 2021 - Present
    • Saint-Hyacinthe, Québec, Canada

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  Capmatic Ltd.

  • Montreal, Canada Area

  • Validation Specialist (Packaging Machinery)

    • Mar 2019 - Apr 2021
    • Montreal, Canada Area

    -Create equipment validation protocols which includes equipment functionality, alarms, and production information.-Drafting and reviewing validation documents for packaging machinery.-Prepare document according to cGMP and GAMP standards such as Design Qualifications (DQ), Functional Specifications (FS), Hardware Design Specifications (HDS), Software Design Specifications (SDS), Factory Site Acceptance Tests (FAT), Installation Qualification (IQ), and Operational Qualification (OQ).-Transferring electrical and pneumatic schematics information into operational tests for IQ & OQ documents.-Assisting and adjusting documentations before, during and after validation execution on site (FAT).-Participating on continuous improvement on the validation protocols and translating manual instructions.- Collaborate with different departments and SMEs’ such as project managers, production managers, service technicians, assemblers, technical writers, mechanical & electrical designers, and HMI screen programmers.

• 

  Prometic

  • Laval, Quebec, Canada

  • Validation Specialist

    • Dec 2016 - Mar 2019
    • Laval, Quebec, Canada

    -Plan and execute equipment qualification & requalification projects for production of plasma products and for quality control laboratory.-Write and execute validation protocols and prepare reports: IOQ,PQ, Deviation .-Participate in shipping validation projects.-Plan and assist on execution of cleaning validation projects: cleaning efficacy & clean hold time for facilities & equipment.-Plan and execute mapping for freezers, refrigerators & incubators.-Create, plan, write, and execute feasibility tests prior validation tests.-Manage every day planning with production and QC for all types of validation projects.- Train personnel for validation execution.- Participate in SOP’s update and continuous improvement.

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  JAMP Pharma Corporation

  • Boucherville, Quebec

  • Quality Assurance Specialist

    • Feb 2016 - Nov 2016
    • Boucherville, Quebec

    Verify documentation of finished products as per USP, Health Canada and cGMPApprove the release of finished productsApprove Certificate of Analysis and other evidence of quality documentationsVerify and approve the release of returned productsUpdate finished products specificationsReview, coordinate, and/or approve CAPA, Change Controls, Deviations & InvestigationsFollow up internal corrective actions and/or investigations.Review production and packaging master document.Participate in problem resolution about the product issuesVerify validation protocol and reports

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  Ropack

  • Montreal, Canada Area

  • Validation Specialist: Equipment, Process & Cleaning

    • Oct 2013 - Aug 2015
    • Montreal, Canada Area

    Execute process validation protocols of bottles and blisters packaging for various clients and various productsWrite and execute equipment validation protocols for various production lineCoordinate cleaning validation projectsManage, plan and execute continuous improvement cleaning projectsCommunicate with different cleaning equipments/accessories suppliers Coordinate temperature and humidity mapping studies of Ropack facilities such as cold room, warehouse, corridor, stability chamber, production room.Update equipment or process validation from Change Controls request and CAPA requestPerform challenge study for vision system in the production line (including risk evaluation)Plan and execute "Performance Qualification" studiesParticipate in Ropack Internal Audit Team

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  Confab Laboratories

  • Validation Specialist

    • Jan 2013 - Jun 2013

    Cleaning ValidationParticipation at the project : CIP ("Clean-in-Place") equipment for dedicated liquid productUpdate memoExecute validation protocols

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  Pharmascience

  • Montreal, Canada Area

  • Internship: Project Engineer

    • Jan 2012 - Apr 2012
    • Montreal, Canada Area

    Planification, coordination and installation of various equipments and building projects.Helping and collaborating with senior and junior project engineers.Equipment projects:vibrating screens, press machine, roller compactor, stability chamber.Building projects: HVAC installation, new gym construction, shipping doors automatisation, space planning.

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  Confab Laboratories

  • Internship: Validation specialist

    • May 2011 - Aug 2011

    Equipment ValidationProcess ValidationCleaning Validation

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  Centre Technologique des Résidus Industriels

  • Rouyn-Noranda

  • Internship: Scientific Analyst

    • Sep 2010 - Dec 2010
    • Rouyn-Noranda

    Working on cellulosic ethanol project.Microbiological and analytical chemistry laboratories testing

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  Environnement Canada

  • Gatineau

  • Internship: Junior Regulation Analysis

    • Jan 2010 - Apr 2010
    • Gatineau

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  Intersand

  • Internship: R&D and AQ Assistant

    • May 2009 - Aug 2009

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  Sistemalux

  • Customer Relations & Sales Coordinator

    • 2007 - 2008

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  Globe Electric

  • Product Development Assistant

    • 2006 - 2007