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CV (Jan 2017)

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CV (Jan 2017)

  1. 1. Scott Dalton Tel: +44 (0)7972 302 731 23 Twycross Grove, Hodge Hill,BirminghamB36 8LB Email: daltons@uni.coventry.ac.uk http://uk.linkedin.com/pub/scott-dalton/59/921/119 Professional Profile A diligentandproven seniorQualityManagementSystem professional with ~4yearsexperience inthe Medical Device industry.Expertiseaccruedthroughaseriesof promotional anddevelopmental opportunitiesspanning QualityAssurance, ProductSafetyand VendorAssurance groups.Thisexperience,leveragedfromastrongBSc Biological Sciences(Hons) degree,hasbenefitedfromrecent BSILeadAuditorandNSFRisk-Based-Decision- Making qualifications thathave translated inthe workplace throughpragmaticandmethodical application. Highlights  QualifiedLeadAuditor ● RiskManagementTrained,Solution-Orientated  ProjectManagement ● HighlyAnalytical,Critical Thinker  System/ProcessTrainer ● ValuedTeamPlayer  SupervisoryExperience ● MicrosoftExcel Expertise  Technical Writing ● SAP,SAPDMS, TrackWise competent Employment Summary Pfizer– InfusionSystems: EMEA Regional Headquarters (1) EMEA SeniorQuality Compliance . Oct 2013 – PresentDay(~4 Years) (2) EMEA Quality Engineer (3) EMEA Data Analyst – Complaintsand Product Safety 1. Coordinate andchairmandatoryQualityManagementReview andOperational Reviewconferencesto continuallyassessthe state of healthof the QualityManagementSystemandcollaborativelyidentify opportunitiesforimprovement amongstseniormanagement. - Monitorand drive compliance acrossall Qualityelements (includingComplaints,CAPA,FieldActions,Change Controls,ManagementControls,Servicing) againstinternal (procedural) andexternal (ISO 13485, Medical Device Directive 93/42/EEC) requirements. - Supervisortoan‘EMEA DocumentControl Specialist’, supportingthatemployee withexecutionof herremitand surpassingpersonal goals. - InternallyqualifiedasanSAP-DMSand TrackWise system trainer,the respectiveapprovedandvalidated documentcontrol andCAPA Investigation repositories. - Facilitate ad-hocNonconformance ReviewBoard(NCRB) meetingstotriage new nonconformancesrelative to risk,assigndispositionactions,actionowners, andfailure codesfortrendanalysis. Trendnonconformances againstpredefinedAcceptable QualityLimits(AQLs) toassessforidentificationof systemicrisks. - Facilitate mandatoryCAPA ReviewBoard(CRB) forums toevaluate Investigationalplanningandprogression status,CAPA proposalsand implantationstatus,Effectivenessof CAPAs toaddressrootcause and reduce nonconformance recurrence likelihoodtoacceptable residual levels. TrainedQA ApproverforCAPA Investigation records in TrackWise. - Responsible forEMEA trainingandiKATassessmentcompliance.Stakeholderinthe restructure of training module designandthe standardisationof tailored trainingprofileglobal rollout. ------------------------------------------------------------------------------------------------------------------------------------------------------- 2. Postattainmentof LeadAuditorstatus,ledamultitude of firstandsecondparty auditsacross EMEA, spanning office-based,manufacturingandservicingenvironmentsin>7 differentcountries. - Designed,developedandimplemented aCAPA-drivenregionalProductComplaintInvestigation(PCI) train-the- trainertrainingprogramme toreviewthe approvedcompliantprocessforinvasive andnon-invasivePCIactivity and recordpopulation. - EMEA Single Pointof Accountability(SPA) forthe Qualityprocesses concernedwithalarge ThirdParty Manufactured (Q-Core) productportfolio wherebyPfizerwere the actingsole distributor.Regional stakeholderin rectifyingquality issues,promotingcompliantconductanddesigningprocessimprovementstrategies (particularly concerningthe complaintmanagementprocess).New ProductLaunches(NPL)were alsoa key prioritywith significantcommercial onus.
  2. 2. - Maintainedsteadyinteractionwith CompetentAuthorities,inparticularwithHPRA andMHRA (leadcompetent authorities),forcommunicatingupdatestoFieldActionactivitiesandforsubmittingresponses/commitmentsto addresscompetentauthorityenquiries. – Change Control Committeedesignee forevaluation/assessmentof proposedprocess/documentationchanges. ------------------------------------------------------------------------------------------------------------------------------------------------------- 3. Developed withinasmall projectteamasemi-automatedexcel-basedComplaintsMonitoringPlatform to measure the timelyreportingandregistrationof new complaintsoriginatingfrom33 EMEA county offices.The model pulled complaintdatafrominboundsite-specificspreadsheetsandtracked themagainstglobal validated Complaintdatabases(INETandTrackWise).Thisplatform exposedcompliance risksforproactive intervention, and non-conformancesforeliminationviathe CAPA system.Findingsweresummarisedandpresenteddailyto Global HQ. This new processincreasedregionalcompliance from92% to >98%. - Createdtrainingslide decksandusermanuals forpurpose of enforcing,viateleconference,approved complaint handlingguidelinesacross all aforementionedsites. - Maintainedacompliance escalationpathwayfromsite personneltocountry/regional/global management. - AuthoredaStandardOperatingProcedure (SOP) toformalise the rolesandresponsibilitiesof thisnew Safety department(ReconciliationDepartment). Highways Agency – Regional Control Centre April 2013 – April 2014 (1 Year 1 Month: Full-Time then Part-Time) Control Room Operator - CompletedanassessedControl RoomOperatorandEmergencyCall Handlingcourse (>90%). - Usedsix major software systemstoproactivelymaintainthe integrityof the strategicroadnetwork,conform to KPItargetsand partake in contingency operations protocol. - Implementedtailoredincident-managementstrategiespertainingtotrafficcollisions,breakdowns,suicide attempts,animalsonthe network&infrastructure defects;andcollaboratedwiththe emergencyservices, breakdownorganisationsandmanagingagentcontractorsinorderto optimize incidentresponse. - Usedradio wave transmissionsandradioterminologytocommunicate withTrafficOfficers. - MaintainedbusinesscontinuityduringCommand&Control systemshutdownperiods. SVA Limited/Exova FoodAnalysisandNutritional Testing Oct 2012 – Feb2013 (5 months)  Laboratory Technician(Chemistry)  Microbiologist Education BSc (Hons) Biological Sciences2:1 306BMS – CancerBiology Health and Life Sciences 302BMS - Clinical Physiology CoventryUniversity2012 307BMS – HumanGeneticsandSociety . 321BMS – AdvancedPharmacologyand DrugDiscovery Dissertation: ‘An Investigation into the Chemotherapeutic Properties of Artemisinin and Two Synthetic Derivatives within Hepatocellular Carcinoma Cell-Culture Assays’. WoundHealingassaysdemonstratedthatArtemisinininhibitedHepG2cell proliferation.The twosynthetic derivativesinvestigated(Artemetherand Artesunate) presented comparableIn Vitro chemotherapeutic properties.Immunohistochemistryassayswere usedtoquantifyproteinexpressionlevels,andidentifieda significantArtemisinin-mediatedincrease inE-cadherin(acell-celladhesionmolecule).Thisindicatesthat Artemisininsanti-cancermode of action(MoA) couldderive fromdecreasedcellularmotility,whichwouldinhibit cancer cell replication andmetastasis. PersonalInformation Hobbies:I am an avidswimmer, andhave the intentionof swimmingthe English Channel inthe summerof 2018. I alsohave a passionforthe outdoors,and regularly compete innational matchfishingcompetitions.Myproudest momentwassettinga venue matchrecordat LavenderHall fisheryinthe summerof 2015, witha 4 hourmatch weightof 107lb 4oz. Referencesare available upon request
  3. 3. Thank You for Your Time

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