BrightOwl Loader Loading

Experiences

Current Experience

  • Consultant


    Since July 2015
    looking for a new projet (Quality Assurance, GMP, gdp, project coordination, business analyst) Looking for a new projet (Quality Assurance, GMP, GDP, project Coordination, Business Analyst)

Past Experience

  • QA Sterility Assurance

    January 2015 --- July 2015
    FDA remediation obs.1 à 4: review of em deviation of the mpu, participation to field investigation release of environmental monitoring test (ud taking) review of environmental monitoring Risk Assessment and environmental monitoring SOP team support in order to do capa contact with operation to ensure application of Quality Systems and support for continuous improvement of sterility assurance activities (kpis, team meeting organisation, Communication improvement)

  • COO Assistant & PMO

    September 2014 --- October 2014
    as pmo: management of the sub-contractor (external suppliers) to ensure project coordination executive assistance for coo http://www.alphanetworks.be/

  • Intérim (Michael Page)

    December 2013 --- September 2014
    in financial departement, SAP team: Quality System implementation; internal science)" rel="nofollow">Protocol creation: writing of all Logistics flow protocols (internal and external flows, mostly for SAP operation), Quality Control protocols and Accounting protocols writing. resellers Sales out data flow and scanning system management: in contact with clr (resellers), monitor the scanning system and follow up of the Sales volume automatic daily upload in bi. ensure point of Sales data accuracy and update management Controller: leonidas Sales data control and monthly Accounting closure 

  • Consultant

    August 2012 --- December 2012
    in order to prepare a FDA inspection in order to respond to the us Food & drugs administration market authorization gap Analysis: review of data transmitted in submission package for gsk us Vaccines vs current Manufacturing protocols in order to build an updated submission package.

  • Consultant

    July 2012 --- August 2012
    in order to meet the modification of european law article 46 regarding paediatric Clinical studies data​: new requirements: all data produced for co-administered Vaccines during Clinical studies involving people under 18 years old must be available and be included in the submission folder of the co-administrated Vaccines  identification of Clinical studies in which Vaccines’ co-administration occurred, collect data link to those other Vaccines in order to prepare an overall submission plan regarding data and additional information produced in paediatric Clinical studies, to be aligned with new european law’s requirements

  • Consultant

    March 2011 --- March 2012
    african amm portfolio status / evaluation contact with african authorities submission folder construction and follow up sample management for africa (command & sending) management of amm portofolio

  • Consultant

    June 2010 --- January 2011
    complains management: problem identification, production data review and complains review approval in SAP global qa complains protocols modification review and implementation of protocols change in production complains Data Analysis: kpi’s management and Data Analysis for quality council monthly meeting

  • Consultant

    May 2007 --- April 2010
    good document practices: contact with Validation to ensure the writing and updating follow up of Qualification documents (GMP document: v-life cycle (urs/iq/oq/co)) administrative management: Training matrix and organisation for primary bulk department, team meeting organization project coordination: o vessel standardization catalogue creation: create a catalogue for gts Engineer and producer with a list of pre-validated equipment parts in order to accelerate the equipment design and order process o GMP support: review of documents related to the equipment design send by suppliers (visits abroad)

  • Consultant

    April 2006 --- April 2007
     creation and management of gts ts acadmy intranet management. find on this site : access to Qualification document template (v-life cycle, protocols and guideline) and planned Training with possibilities to subscribe  « hand over » practices improvement between gts and users  video Training creation  Training organization

  • QC Lab Operator

    September 2005 --- April 2006
    Quality Control : contol of raw materials in laboratories based on european pharmacopoeia protocols

Personality

Self Assessment :
AssertivenessInterest in knowledgeCollaborationCoordinationCritical thinkingCuriosityIndependenceProblem solvingReaction to stressAdaptabilityAnalytical thinkingAuthenticityEfficiencyKindnessOrganizationSociability

Knowledge

Self Assessment :
Pharmaceutical IndustryFood IndustryvaccinsCAPAChemistryData AnalysisWriting Study Procedures and SOPsVerificationSOPData ManagementGood Manufacturing Practice (GMP)Knowledge of the drug development processLaboratoryProcess improvementStatistical considerations in design and analysisQuality Assurance (QA)
LinkedIn Assessment :
FrenchProject ManagementsustainabilityEnglishManagement ConsultingBusiness StrategyBusiness IntelligenceAnalysisProject CoordinationProcess improvementEuropean UnionTeam LeadershipGMPQuality Assurance (QA)Quality Control (QC)Document ManagementDocument ReviewDeviationsChange ManagementBusiness AnalysisConsulting

Skills and Expertise

Self Assessment :
Written presentation Create SOPs Develop protocolsAdministrative supportDocument data collection systemCoachCollaborate with principal investigatorDocument data reporting systemsDocument employees training requirementsFollow-up of Quality Management System (QMS) processesFollow-up of quality assurance activitiesManage laboratory proceduresObserve trends in dataProtocol managementReview quality control activities

Education

  • Master of Environmental Science and managment in (still on going) from Université libre de Bruxelles in 2012
  • Bachelor of Chemistry in Option: Environmental from Institut Paul Lambin in 2005

Training and Certification

  • Aseptic practices in 2015 Training
  • GMP in 2010 Training
  • ISO9001/2008 in 2009 Training
  • BPMN in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency

Area / Region

Brussels, Belgium

Others

Driving License
  • No

Similar Candidates

Other Candidates in Belgium

Other Candidates in Brussels

Other similar Candidates in Brussels

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like