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Summary

quality: Quality Systems (exceptions /non conformity /deviation, capa, complaints, audits, Training, Documentation /SOP, validations/iq/oq/pq …), audits (internal audits, client audits, supplier audits) validations: iq/oq/pq for equipments and areas, cleaning /decontamination /Sterilization validations and periodic /intercampaign validations of equipments, areas, gas, water, pure steam, process and operators (internal or contractors) environmental monitoring (microbiological and non viable /particular) for areas, process, operators (only microbiological), gas (co2, n2, ca), water and pure steam (wfi, pw, dw, row, ps) Manufacturing : organization, management, planing, Training cleaning : management of internal teams and contractors, SOP, validations, material cleaning /decontamination /Sterilization, area cleaning /decontamination /Sterilization, water loops /tanks /units cleaning /decontamination /Sterilization ... Project Management: urs, basic and detail designs, follow up of the project (contractors, project team, planing, validations) and iq/oq/pq work environment : pharma GMP (FDA …), Food Industry GMP (ifs, HACCP …)

Experiences

Current Experience

  • Quality Standards and Systems Leader

    Zaventem, Belgium
    Since January 2016

Past Experience

  • Project Manager

    March 2015 --- December 2015

  • Manufacturing Manager

    March 2013 --- February 2015

  • Production Manager

    March 2012 --- February 2013

  • Consultant

    January 2012 --- March 2012

  • Quality Manager

    July 2011 --- November 2011
    quality responsible for the 3 units of terbeke wanze (Food Industry) responsible for the Quality Systems follow up, coordination and supervision responsible for the quality equipments (rx detector, metal detector, checkweigher ...) responsible for the cleaning (internal cleaning and contractors) HACCP, ifs, GMP audits

  • Quality Assurance (QA) Manager

    November 2010 --- July 2011
    Quality Systems responsible for the baxter Bioscience belgium responsible for the Quality Systems (exceptions, capa, Change Control, Documentation and labelling) follow up, coordination and supervision

  • Manufacturing Facilities Gosselies / GMP Production Associate Director

    February 2009 --- November 2010
    direction of gosselies production unit responsible for the quality Operations (non-conformity, capa, Change Control, Documentation, Training) facilitiy manager follow up, coordination and supervision Manufacturing Planning responsible for the Manufacturing and logistic teams audits

  • Production Manager

    October 2007 --- January 2009
    responsible for the quality operation (deviation, capa, request for process change, procedure, Training) follow up, coordination and supervision Manufacturing (bulk production and Formulation) Planning responsible for the teams of media preparation, Cell and viral culture and Formulation ehs Coordinator tqm Coordinator audits responsible of the equipment of the unit Project Manager as user for the upgrading of 2 Cell and viral culture areas: 1. urs, basic design, detail design 2. weekly meeting with project team (snc lavalin) 3. daily contact with the contractor and daily follow up of the project progress 4. iq/oq/pq 5. scopes : new incubators class b (4/area) with independent hvac and new system of regulation, sealing of the 2 areas (areas with negative pressure), agv (automated guided vehicle)

  • Production Supervisor

    October 2005 --- September 2007
    responsible for the quality operation (deviation, capa, request for process change, procedure, Training) follow up, coordination and supervision Manufacturing (bulk production and Formulation) Planning responsible for the teams of media preparation, Cell and viral culture and Formulation ehs Coordinator tqm Coordinator audits responsible of the equipment of the unit

  • Research Scientist - Professor assistant (FUSAGx)

    January 2001 --- January 2005
    molecular biology, Microbiology, cancerology and genetic

Knowledge

LinkedIn Assessment :
GMPMicrobiologymolecular biologyBiotechnologycGMPSix SigmaQuality Assurance (QA)ManufacturingQuality SystemsR&DLife SciencesQuality ManagementFDA

Education

  • Ph.D. in Agronomic Sciences and Bioengineering from Faculté universitaire des Sciences agronomiques de Gembloux in 2009
  • DEA in Agronomic Sciences and Bioengineering from Faculté universitaire des Sciences agronomiques de Gembloux in 2003
  • M.Sc. in Agronomic Sciences and Bioengineering from Faculté universitaire des Sciences agronomiques de Gembloux in 2001

Area / Region

Belgium

Others

Driving License
  • Yes

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