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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