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Experiences

Current Experience

  • Validation Engineer

    Beerse, Belgium
    Since January 2018

    1) designing, implementing and leading a custom agile based development approach for development of new Lab Automation Software within j&j's pdms afs. the newly developed Software will replace obsolete lea Software and will provide a user friendly top layer communicating with hamilton's and chemspeed's instrument control.
    analyzing and mapping Lab Business Processes and screens and providing a Lab catalogue to clients and users, containing procedures, technical documents and manuals.

    2) perform Validation activities according to j&j's sdlc (waterfall track) to support the implementation and Qualification of the syntq control client on a drug Manufacturing line. assess Validation needs and provide and follow up on necessary Documentation and milestones.

    1) Designing, implementing and leading a custom Agile based development approach for development of new lab automation software within J&J's PDMS AFS. The newly developed software will replace obsolete LEA software and will provide a user friendly top layer communicating with Hamilton's and ChemSpeed's instrument control.
    Analyzing and mapping lab business processes and screens and providing a lab catalogue to clients and users, containing procedures, technical documents and manuals.

    2) Perform validation activities according to J&J's SDLC (Waterfall track) to support the implementation and qualification of the SYNTQ control client on a drug manufacturing line. Assess validation needs and provide and follow up on necessary documentation and milestones.

  • Regulatory Compliance Consultant

    Diegem, Machelen, Belgium
    Since September 2012

Past Experience

  • Validation engineer Beerse, Belgium

    September 2016 --- May 2017

    1) designing and implementing a custom agile based development approach for development of new Lab Automation Software within j&j's pdms afs. the newly developed Software will replace obsolete lea Software and will provide a user friendly top layer communicating with hamilton's and chemspeed's instrument control.

    2) Validation of templates/spreadsheets and managing changes in electronic Lab notebook (eln) environment

     

  • Validation Engineer Beerse, Belgium

    July 2016 --- August 2016

    follow-up of Project Management and Validation activities during the holidays, replacing the Project Engineer responsible for a certain patient registration Software used in compassionate Treatment. acting on emergency changes, managing Validation activities, liaising between business stakeholders, Clinical it department and the Software vendor to ensure acceptance and validated state of the system. creating Validation Documentation and test scripts using hp alm. lead review and approval cycles.

  • Validation Consultant for CTG Belgium Braine-l'Alleud, Belgium

    November 2015 --- March 2016

    executing periodic reviews of it GXP validated systems within the it Compliance solutions department. performing gap Analysis on system Documentation, Consulting regarding action plans to be put in place.

  • Regulatory Compliance Consultant

    September 2012 --- April 2015
    current assignment: quality Engineer @ j&j Clinical pharmacology unit

  • Quality Engineer @ J&J Clinical Pharmacology Unit

    September 2012 --- April 2015
    responsible for Quality Management maintenance, development and continuous improvement, optimizing the cpu processes and Quality Systems. assuring the internal processes supported by systems, people and procedures comply with regulations. maintain inspection readiness, facilitate audits and inspections at cpu. set up, execute and reinforce programs for capa and deviation handling, Risk Management, internal audits and management review.

  • Product Researcher R&D Strombeek, Grimbergen, Belgium

    May 2010 --- August 2012

    support new product initiatives and commercial initiatives on in-market products (dish washing liquids dept.), acting as the connection between product developers, Marketing and supporting functions. develop and validate test methods and sops to determine, compare and demonstrate product performance. Coach Lab personnel on accurate execution of these methods in line with sops.

  • Master's Thesis Internship

    January 2010 --- June 2010
    revision of HACCP and prerequisite program - integrate pharma-Validation master’s thesis: integration of Pharmaceutical Validation and HACCP

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailFlexibilityKindnessProblem solvingReaction to stressSociabilityCollaboration

Knowledge

Self Assessment :
Quality ManagementCAPA Phase I R&DClinical pharmacologyClinical trial audits and inspectionsClinical trialsFDAGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)ICH-GCPInformed Consent ProcessIt skillsMicrosoft OfficeSOPTrainingValidationWriting Study Procedures and SOPs
LinkedIn Assessment :
Quality SystemsValidationRegulatory ComplianceCoachingQuality ManagementProject ManagementGCPGMPRisk ManagementQuality Assurance (QA)Procedure DevelopmentCAPATrackwiseEnglishBiotechnologyProduct developmentLife SciencesTrainingICH-GCPR&D

Skills and Expertise

Self Assessment :
Create SOPs Guide students Report dataAdjust processes and methodsCoachCollaborate with medical teamDevelop ICH/GCP compliant processesEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of internal auditsFollow-up of Quality Management System (QMS) processesGuide staffImplement Quality Management System (QMS)Maintain Quality Management System (QMS)Oral presentationPrepare internal auditsProvide trainingRespond to audit findingsSolve problemsTrain on site staffAgile methodologySDLCproject managementRegulatory documentation

Education

  • Master in Industrial Sciences - Biochemistry from Groep T - Internationale Hogeschool Leuven in 2010

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Elementary Proficiency
Dutch
Native

Work Preferences

  • Locations I am interested in:
    Antwerp, Belgium Beerse, Belgium Eindhoven, Netherlands Geel, Belgium Haasrode, Belgium Hasselt, Belgium Leuven, Belgium Liège, Belgium Limburg, Belgium Lummen, Belgium Maastricht, Netherlands Vlaams-Brabant, Belgium Wavre, Belgium
  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    No

Area / Region

Limburg, Belgium

Others

Driving License
  • Yes

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