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JonathanKing CV Ph: 0420 943 932 Page 1 of 4
Jonathan King
CurriculumVitae
Phone:0426 822 121
E-mail:jonathan.king78@gmail.com
About me I am a projectleaderwith expertise inthe developmentandimprovementof
qualitymanagementsystems andthe technical processes. Myaptitude for
workingwithpeople,developinguserbased systemsandmyknowledgeof
currentregulationsallows me thrivein afast paced,highlyregulatedand
complex workplace.
I take every opportunitytofurtherenhance myknowledge,experience and
expertiseanduse thisto extendthe training andabilitiesof myteams.
Skills  Skillsinthe practical applicationof statistical processcontrols,Lean,Six-
Sigmaand KepnerTregoe
 Managementandtrainingof personnel andteams atvarious
organizational levels
 Advancedtechnical writingskills
 Biological andchemical processengineering
 Technical knowledge andprocess transfer
 Audit– GMP, Quality,product, environmental, processanddocument
 Publicspeakingandcommunication
Knowledge  All facetsof qualitymanagement
 CurrentISO9001, ISO 13485, ISO14001 & AS 4801 requirements
 Regulatoryknowledge of PIC/S,ICH,USFDA,MHRA, Medsafe andTGA
 HAZOP,HACCP,RCA,TQPP,CQA,CCP,CPP
 Process,cleaningandequipment Validation(IQ,OQ,PQ)
 Extensive knowledgeof variousqualitymanagementsystems(QMS)
 Engineeringoperations,validationandprojectmanagement
Career
highlights
 EstablishedandmanagedmultipleQualityManagementSystemstoISO,
FDA 21 CFR andPIC/S GMP standards
 International technical transferof tabletprocesses
 Validation of watersystem, stabilitychambers,cleaning,centrifugeand
industrial mills.
 Applicationof 5Sand leanmethodologiesforamedical device business
 Productanalysis,investigationandimprovement usingLean-Six-Sigma
and otherprocessimprovementapproaches
Qualifications  Bachelorof TechnologyinBio-ProcessEngineering(BPE)
 Post-Graduate DiplomainQualitySystems(PGDipQS) withdistinction
 Charteredmemberof the CharteredQualityInstitute(CQI)
 CompetentCommunicator(ToastMastersInternational)
JonathanKing CV Ph: 0420 943 932 Page 2 of 4
Professional experience
PharmOut (Aus), Quality Consultant, April 2014 ongoing
PharmOutisa pharmaceutical consultancyfocusedon‘Regulatoryknowledge, practically
applied’.AsaconsultantforPharmOut,usingprojectmanagementtechniques, Ihave:
 workedina varietyof qualitymanagementroles
 writtennewandredevelopedexisting QualityManagementSystems(QMS) tomeetthe
PIC/Sand ISOstandard requirementsandtrainedpeopleinhow touse and run theirQMS
 workedto replace the BPCScomputerisedsystemwith SAP
 workedonvalidationprojectsforequipment,processandcleaning validation
 presented ontechnical transferatthe AustralianNational ValidationForum
 conductedproductqualityinspections
 developed trainingpackagesforcurrentGoodManufacturingPractice (cGMP)
Integrated Bulk Systems (Aus), Quality Manager, July 2012 to April 2014
IntegratedBulkSystems(IBS) isanEngineering, Procurement,ConstructionManagement
(EPCM) businessfocusedontechnical andinnovativebulkmaterialsprocessingandtransport
systems.Asthe QualityManagermyrole included:
 writingthe QMS processesanddocuments tomeetthe requirementsof ISO9001, ISO14001
and AS4801
 achievingcertification of the QMS to ISO9001:2008
 representingthe companyforcustomerandISOauditsand inspections
 developingandmanagingthe documentandrecordcontrol system
 runninginductionsandtrainingnew andexistingstaff inthe QMS
 overseeingthe vendormanagementsystems
 managingall non-conformance investigationsandCAPA activitiestocompletion
CSL (Aus), Quality and Systems Engineer, January 2011 to September 2012
CommonwealthSerumLaboratories(CSL) isalarge bio-pharmaceutical company.Asthe Quality
and SystemsEngineerforthe EngineeringServicesDepartment(ESD) myrole included:
 managingvariousQMS and processimprovementprojects
 benchmarkingandestablishingcommonbestpractice acrossthe Broadmeadowsand
Parkville sitesforthe electrical,instrumentation,automationandmaintenancegroups
 managingotherstaff responsible forharmonisingbestpractice acrossthe twosites
 revisingandconsolidatingover100 qualitycontrolleddocumentsforESD
 establishingaholisticmaintenance requestandmanagementprocess
 completing‘superuser’responsibilitiesforthe Enterprise AssetManagement(EAM) system
 settingthe performance metricsforthe ESDgroups
 applyingmysubjectmatterexpertise tocontribute toasix-sigmaprojectforoptimisingthe
vendormanagementprocessesandrelatedsystems
 frontingforan ISO9001:2008 recertificationauditforthe ESD groups
JonathanKing CV Ph: 0420 943 932 Page 3 of 4
Professional experience
ACC (NZ), Process Analyst, February 2009 to November 2010
The AccidentCompensationCorporationisastate ownedenterprise responsible formanaging
compensationforall accidentvictimsinNew Zealand.Asaprocessanalystmyrole included:
 engagingsubjectmatterexpertstodevelopnewandrevise existinghealthcare processes
for staff acrossall branchesaroundNew Zealand
 analysingbusinessprocessesandstrategiestoengineerimprovementopportunities
 applyingmy technical writingexpertisetodevelopuserbasedcase management
proceduresandforms
GSK (UK), Senior Process Engineer/ Technologist, August 2004 to October 2008
GlaxoSmithKline (GSK) isaglobal pharmaceutical company.The Ware site isthe principle new
productand global supply(NP&GS) site of the GSKnetworkfororal soliddose medicines.Asa
SeniorProcessEngineer/Technologistmyrole included:
 line managementfortablettrialsandinvestigations
 NewProductIntroduction(NPI) anddevelopmentfromR&Dto global supply
 leadingtechnical transfersof products andprocesses tothirdpartymanufacturers
 leadingproductandprocess investigation projects
 completingprocessandcleaningvalidationprojects
 leadingplannedchanges forchange monitoring,evaluationandvalidation
 developinganddeliveringtraininginbestpractice forpowdergranulation,compression,
tabletcoatingand tabletpackingprocesses, RCA andstatistical processcontrol
 setupof product SAPcodes and improvementof the SAPcode setupprocess
AQUI-S (NZ), Operations Manager, June 2002 to February 2004
AQUI-Sisa small manufacturerof aquaculture anaestheticsandotherproductsforthe
husbandry,transportandharvestingof fishandwaterbasedanimals.Asthe Operations
Manager my role included:
 managingall businessoperationalandHACCPactivities
 developingandmaintainingall QMSsystems,documentsandrecords
 developingnewproductsandintroducingnew technologiessuchasinductionseals
 managingstabilitytrials andcleaningvalidationprojects
 managingoperationsandlaboratorypersonnel,suppliersandservice providers
 procurement,managementandcontrol of raw materialsandservice providers
Schering-Plough Animal Health (NZ), Antigen Technician, Jan 2001 to Feb 2002
Schering-PloughAnimal Health(SPAH) NZLtdwasa global leaderinthe research,development,
manufacturingandsale of veterinarymedicines. AsanAntigenTechnicianmyrole included:
 fermentingandinactivatingaerobicandanaerobicbacteriafrom seedto3000L.
 asepticallyinoculatingandtransferringmediaandculturesacrossproductionareas
 concentratingantigensusingacentrifugationprocess
 completinglaboratorytestingandanalysisof antigens,mediaandcontaminants
 maintainingbacterial seedstockandformalinequipment
 sterilising/sanitisingrooms,devicesandequipment accordingtoHACCPrequirements
JonathanKing CV Ph: 0420 943 932 Page 4 of 4
Professional courses and training
Company Course
Toastmasters Competentcommunicator
NVF AustralianNational ValidationForum2015 and masterclasses
PharmOut QualityRiskManagement
PharmOut StatisticsforProcessValidation
PharmOut Pharmaceutical PlantSustainableDesign
PharmOut Good DistributionPractice
PharmOut Good WarehousingPractice
PharmOut Good ManufacturingPractice
PharmOut ISO14644 & Cleanrooms
PharmOut GAMP 5
PharmOut ComputerSystemValidation(CSV)
PharmOut 10 GoldenRulesof GMP
PharmOut GMP RefresherTraining
PharmOut Annex 15 – QualificationandValidation
PharmOut ProcessValidation
PharmOut GMP documentation
PharmOut Pharmaceutical QualityRiskManagement
SAIGlobal Internal AuditorTraining
CSL Enterprise AssetManagement(EAM)
CSL SmartSolve,SmartDocumentandSmartAudit
Tactics MappingInformationforpaper,online andweb
Skillpath How to be a highlyeffective teamleader
ACC Healthand safetyrepresentativescourse- stage 1
GSK Advocate Greenbelt6-sigmatraining
GSK Auditortraining- level 1,2 and 3
GSK Tabletand powdertechnology
GSK Kanban
GSK KepnerTregoe
GSK Lean Six Sigma
GSK Secondaty Pharmaceutical Processes
GSK SOPAuthorand Authorisertraining
GSK Technical documentwriting
GSK Designof Experiment(DoE)
Colorcon Industrial Coating
Glatt FluidBedDryingandCoating
Referees
Available onrequest

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Resume February 2016

  • 1. JonathanKing CV Ph: 0420 943 932 Page 1 of 4 Jonathan King CurriculumVitae Phone:0426 822 121 E-mail:jonathan.king78@gmail.com About me I am a projectleaderwith expertise inthe developmentandimprovementof qualitymanagementsystems andthe technical processes. Myaptitude for workingwithpeople,developinguserbased systemsandmyknowledgeof currentregulationsallows me thrivein afast paced,highlyregulatedand complex workplace. I take every opportunitytofurtherenhance myknowledge,experience and expertiseanduse thisto extendthe training andabilitiesof myteams. Skills  Skillsinthe practical applicationof statistical processcontrols,Lean,Six- Sigmaand KepnerTregoe  Managementandtrainingof personnel andteams atvarious organizational levels  Advancedtechnical writingskills  Biological andchemical processengineering  Technical knowledge andprocess transfer  Audit– GMP, Quality,product, environmental, processanddocument  Publicspeakingandcommunication Knowledge  All facetsof qualitymanagement  CurrentISO9001, ISO 13485, ISO14001 & AS 4801 requirements  Regulatoryknowledge of PIC/S,ICH,USFDA,MHRA, Medsafe andTGA  HAZOP,HACCP,RCA,TQPP,CQA,CCP,CPP  Process,cleaningandequipment Validation(IQ,OQ,PQ)  Extensive knowledgeof variousqualitymanagementsystems(QMS)  Engineeringoperations,validationandprojectmanagement Career highlights  EstablishedandmanagedmultipleQualityManagementSystemstoISO, FDA 21 CFR andPIC/S GMP standards  International technical transferof tabletprocesses  Validation of watersystem, stabilitychambers,cleaning,centrifugeand industrial mills.  Applicationof 5Sand leanmethodologiesforamedical device business  Productanalysis,investigationandimprovement usingLean-Six-Sigma and otherprocessimprovementapproaches Qualifications  Bachelorof TechnologyinBio-ProcessEngineering(BPE)  Post-Graduate DiplomainQualitySystems(PGDipQS) withdistinction  Charteredmemberof the CharteredQualityInstitute(CQI)  CompetentCommunicator(ToastMastersInternational)
  • 2. JonathanKing CV Ph: 0420 943 932 Page 2 of 4 Professional experience PharmOut (Aus), Quality Consultant, April 2014 ongoing PharmOutisa pharmaceutical consultancyfocusedon‘Regulatoryknowledge, practically applied’.AsaconsultantforPharmOut,usingprojectmanagementtechniques, Ihave:  workedina varietyof qualitymanagementroles  writtennewandredevelopedexisting QualityManagementSystems(QMS) tomeetthe PIC/Sand ISOstandard requirementsandtrainedpeopleinhow touse and run theirQMS  workedto replace the BPCScomputerisedsystemwith SAP  workedonvalidationprojectsforequipment,processandcleaning validation  presented ontechnical transferatthe AustralianNational ValidationForum  conductedproductqualityinspections  developed trainingpackagesforcurrentGoodManufacturingPractice (cGMP) Integrated Bulk Systems (Aus), Quality Manager, July 2012 to April 2014 IntegratedBulkSystems(IBS) isanEngineering, Procurement,ConstructionManagement (EPCM) businessfocusedontechnical andinnovativebulkmaterialsprocessingandtransport systems.Asthe QualityManagermyrole included:  writingthe QMS processesanddocuments tomeetthe requirementsof ISO9001, ISO14001 and AS4801  achievingcertification of the QMS to ISO9001:2008  representingthe companyforcustomerandISOauditsand inspections  developingandmanagingthe documentandrecordcontrol system  runninginductionsandtrainingnew andexistingstaff inthe QMS  overseeingthe vendormanagementsystems  managingall non-conformance investigationsandCAPA activitiestocompletion CSL (Aus), Quality and Systems Engineer, January 2011 to September 2012 CommonwealthSerumLaboratories(CSL) isalarge bio-pharmaceutical company.Asthe Quality and SystemsEngineerforthe EngineeringServicesDepartment(ESD) myrole included:  managingvariousQMS and processimprovementprojects  benchmarkingandestablishingcommonbestpractice acrossthe Broadmeadowsand Parkville sitesforthe electrical,instrumentation,automationandmaintenancegroups  managingotherstaff responsible forharmonisingbestpractice acrossthe twosites  revisingandconsolidatingover100 qualitycontrolleddocumentsforESD  establishingaholisticmaintenance requestandmanagementprocess  completing‘superuser’responsibilitiesforthe Enterprise AssetManagement(EAM) system  settingthe performance metricsforthe ESDgroups  applyingmysubjectmatterexpertise tocontribute toasix-sigmaprojectforoptimisingthe vendormanagementprocessesandrelatedsystems  frontingforan ISO9001:2008 recertificationauditforthe ESD groups
  • 3. JonathanKing CV Ph: 0420 943 932 Page 3 of 4 Professional experience ACC (NZ), Process Analyst, February 2009 to November 2010 The AccidentCompensationCorporationisastate ownedenterprise responsible formanaging compensationforall accidentvictimsinNew Zealand.Asaprocessanalystmyrole included:  engagingsubjectmatterexpertstodevelopnewandrevise existinghealthcare processes for staff acrossall branchesaroundNew Zealand  analysingbusinessprocessesandstrategiestoengineerimprovementopportunities  applyingmy technical writingexpertisetodevelopuserbasedcase management proceduresandforms GSK (UK), Senior Process Engineer/ Technologist, August 2004 to October 2008 GlaxoSmithKline (GSK) isaglobal pharmaceutical company.The Ware site isthe principle new productand global supply(NP&GS) site of the GSKnetworkfororal soliddose medicines.Asa SeniorProcessEngineer/Technologistmyrole included:  line managementfortablettrialsandinvestigations  NewProductIntroduction(NPI) anddevelopmentfromR&Dto global supply  leadingtechnical transfersof products andprocesses tothirdpartymanufacturers  leadingproductandprocess investigation projects  completingprocessandcleaningvalidationprojects  leadingplannedchanges forchange monitoring,evaluationandvalidation  developinganddeliveringtraininginbestpractice forpowdergranulation,compression, tabletcoatingand tabletpackingprocesses, RCA andstatistical processcontrol  setupof product SAPcodes and improvementof the SAPcode setupprocess AQUI-S (NZ), Operations Manager, June 2002 to February 2004 AQUI-Sisa small manufacturerof aquaculture anaestheticsandotherproductsforthe husbandry,transportandharvestingof fishandwaterbasedanimals.Asthe Operations Manager my role included:  managingall businessoperationalandHACCPactivities  developingandmaintainingall QMSsystems,documentsandrecords  developingnewproductsandintroducingnew technologiessuchasinductionseals  managingstabilitytrials andcleaningvalidationprojects  managingoperationsandlaboratorypersonnel,suppliersandservice providers  procurement,managementandcontrol of raw materialsandservice providers Schering-Plough Animal Health (NZ), Antigen Technician, Jan 2001 to Feb 2002 Schering-PloughAnimal Health(SPAH) NZLtdwasa global leaderinthe research,development, manufacturingandsale of veterinarymedicines. AsanAntigenTechnicianmyrole included:  fermentingandinactivatingaerobicandanaerobicbacteriafrom seedto3000L.  asepticallyinoculatingandtransferringmediaandculturesacrossproductionareas  concentratingantigensusingacentrifugationprocess  completinglaboratorytestingandanalysisof antigens,mediaandcontaminants  maintainingbacterial seedstockandformalinequipment  sterilising/sanitisingrooms,devicesandequipment accordingtoHACCPrequirements
  • 4. JonathanKing CV Ph: 0420 943 932 Page 4 of 4 Professional courses and training Company Course Toastmasters Competentcommunicator NVF AustralianNational ValidationForum2015 and masterclasses PharmOut QualityRiskManagement PharmOut StatisticsforProcessValidation PharmOut Pharmaceutical PlantSustainableDesign PharmOut Good DistributionPractice PharmOut Good WarehousingPractice PharmOut Good ManufacturingPractice PharmOut ISO14644 & Cleanrooms PharmOut GAMP 5 PharmOut ComputerSystemValidation(CSV) PharmOut 10 GoldenRulesof GMP PharmOut GMP RefresherTraining PharmOut Annex 15 – QualificationandValidation PharmOut ProcessValidation PharmOut GMP documentation PharmOut Pharmaceutical QualityRiskManagement SAIGlobal Internal AuditorTraining CSL Enterprise AssetManagement(EAM) CSL SmartSolve,SmartDocumentandSmartAudit Tactics MappingInformationforpaper,online andweb Skillpath How to be a highlyeffective teamleader ACC Healthand safetyrepresentativescourse- stage 1 GSK Advocate Greenbelt6-sigmatraining GSK Auditortraining- level 1,2 and 3 GSK Tabletand powdertechnology GSK Kanban GSK KepnerTregoe GSK Lean Six Sigma GSK Secondaty Pharmaceutical Processes GSK SOPAuthorand Authorisertraining GSK Technical documentwriting GSK Designof Experiment(DoE) Colorcon Industrial Coating Glatt FluidBedDryingandCoating Referees Available onrequest