BrightOwl Loader Loading

Experiences

Current Experience

  • Production Engineer BFS


    Since January 2015

Past Experience

  • Qualified Person Trainee

    July 2014 --- January 2015
    Trainee Qualified Person - product support components & devices

  • Trainee

    September 2012 --- May 2013
    traineeship within the department of cmc dossier development & Operations, as part of master's degree in Drug Development

Personality

Self Assessment :
SociabilityAdaptabilityAnalytical thinkingAttention to detailCharmCoordinationCritical thinkingCuriosityDependabilityFlexibilityInterest in knowledgeKindnessProblem solvingTrustWillingness to compromiseApproachabilityCollaboration

Knowledge

Self Assessment :
Actions and modes of action of drugs in the human speciesAnimal trialAnimal ModelsCAPAData AnalysisEnglishFDADrug development processCMC Drug regulatory authoritiesGMPGood Manufacturing Practice (GMP)Good Laboratory Practice (GLP)HPLCICH GCP guidelinesIMPDINDKnowledge of the drug development processMarketing Authorisation Application (MAA)Medical DevicesMicrosoft OfficeMicrosoft ExcelNew Drug Application (NDA)PCRPharmaceutical IndustryPharmacovigilancePilot scale batchesPowerPointProblem-solving methods and troubleshootingQuality Assurance (QA)Randomization and blindingRegistration of the productRegulatory submissionsScientific WritingSOPStatisticsStrategic PlanningTime ManagementUnderstanding of regulatory guidelinesValidationQualificationWriting Study Procedures and SOPsVerification
LinkedIn Assessment :
Pharmaceutical IndustryScientific WritingLife SciencesEnglishMicrosoft OfficeGMPPharmaceutics

Skills and Expertise

Self Assessment :
Create SOPs Interpret data Report dataAdjust processes and methods Analyze dataArchive documentationAssist with experimentsAssist with proceduresChemistry Manufacturing and Controls (CMC) activitiesCollaborate with project teamCommunicate with investigatorCommunicate with sponsorConduct university research Create SOPsCreate standard operating procedure (SOP)Data analysisData entryDirect co-workersEvaluate protocolsGenerate regulatory submissions Manufacture of non-GMP and GMP batchesMonitor dataNetworkOral presentationOperate research equipmentObserve trends in dataOrganise meetingsPrepare CMC source documents related to clinical trial applicationProvide input to process improvement initiativesPilot scale batchesRead medical literatureWritten presentationWork under specific instructionsStorytellingSolve problemsStatistical analysisReport study conclusionsReport data

Education

  • Master of Science (MSc) in Industrial Pharmacy from Katholieke Universiteit Leuven in 2014
  • Master of Science (MSc) in Drug Development from Katholieke Universiteit Leuven in 2013
  • Bachelor of Science (BSc) in Pharmaceutical Sciences from Katholieke Universiteit Leuven in 2011

Training and Certification

  • Laboratory Animal Sciences 1 in 2012 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Research Associate (CRA) Clinical Research Associate (CRA) Project Engineer Team Leader Production Supervisor Process Engineer Product Specialist
  • Locations I am interested in:
    Australia Belgium Ireland
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

Leuven, Belgium

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Belgium

Other Candidates in Leuven

Other similar Candidates in Leuven

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like