Kanth CV (14..01.2017)

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V. L. KANTHACHARI PUSAPTI
Proficient in running successful method-oriented operation and taking initiatives for
business excellence through qualification & Validations
Industry Preference: Pharmaceuticals
Location Preferences: USA, UK, SINGAPORE, MALASIA & INDIA
KeySkills
StrategicPlanning
Validation
Quality&Compliance
Production operations
Resourcemanagement
Training &Development
Internal audits
TeamManagement
ProfileSummary
 A dynamic professional with nearly 19 years & 10 months of
experiencein PharmaceuticalandHealthcare sector.
 Currently associated with Sun Pharm Industries Limited,
Mumbai, India as General Manager –Validation, Sun Global
Operations.
 Comprehensive experience in equipment / systems validation
process which relates to establishment of documentary
evidence depicting procedure, process or activity which is
undertaken in production, testing and warehousing areas by
ensuring maintenance of desired level of compliance at all
stages.
 Proficient in computer systems / PLC validations, and
experiencein GxP impactassessmentasper ISPE guidance,
Functional &Quality riskassessmentasperICHQ9 &GAMP
5 andPart 11 assessmentaspartof 21CFR.
 Hands on experience in Process validation and cleaning
validations aspercurrentregulatoryrequirements.
 Proficientindeveloping& streamlining validation systems with
proven capabilityto enhanceoperationaleffectivenessandmeet
operationalgoalswithinthecost, time& quality parameters.
 Sound practical knowledge regarding capacity, planning and
conducting validation activities and participating in
regulatoryand internal audits.
 Experience in conceptualizing profitable production operations
encompassing procurement,qualityand industrial relations.
 Skilled in enhancing production process operations, optimizing
resource utilization, escalating productivity and operational
efficiencies.
 Possess strong research, analytical, problem-solving and
interpersonalcommunicationskills.
kanth_1969@yahoo.co.in +91-7506550940 +91-7032738940

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Career Timelines
 SinceOct’2016 to tilltoday with Sun PharmaIndustriesLtd., Mumbai,Maharashtra,Indiaas GM –CQA (Validation),
Sun GlobalOperations.
 Feb’ 2015 – Oct’ 2016 (1 year and 7 months) with Gland Pharma Limited, Hyderabad, A.P., India as
DGM –CQA (Validation)
 Feb’ 2011– Feb’ 2015(4year) with HospiraHealthcareIndiaPvt. Ltd., Visakhapatnam,India as DGM –QA (Validation)
 Jul’ 2009 – Feb’ 2011 (1 year and 7 months) with Plethico Pharmaceuticals Limited, Kalaria, Indore, India as
Sr. Manager– QA (Validation)
 May’ 2003 – Jul’ 2009 (6 year and 3 months) with Orchid Healthcare, Generics, Irungattukottai, Chennai, India as
Manager–QA (Validation)
 Mar’ 1997– May’ 2003(6 year and3 months)with GlandPharmaLimited,Hyderabad,India as Executive – Production
AcademicProfile
 (Ph.D.) (Part time) – Pursuing – from Andhra University, Visakhapatnam,India
 1996 M. Pharm (Biotechnology) – Firstclass – 72.2% – from Andhra University, Visakhapatnam,India
 1994 B. Pharm – First class – 64.5% – from Andhra University, Visakhapatnam,India
 1989 D. Pharm – First class – 80.7% – from Andhra University, Visakhapatnam,India
Orchid Healthcare,
Chennai
Manager – QA (Validation)
Hospira Healthcare India Ltd.,
Visakhapatnam
DGM – QA (Validation)
Sun Pharma Industries Ltd.,
Mumbai
GM–Validation,
Sun Global Operations
Feb’ 11 - Feb’ 15 Jul’ 09 - Feb’ 11Feb’ 15 - Oct 16 Mar’97 - May’03Since Oct 2016 till
today
May’ 03 - Jul’ 09
Plethico Pharmaceuticals Ltd.,
Indore
Sr. Manager – QA (Validation)
Gland Pharma Ltd.,
Hyderabad
DGM – CQA (Validation)
Gland Pharma Ltd.,
Hyderabad
Executive – Production

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Professional Experience
Role:GM-Validation (Sun Global Operations) Oct’ 2016 – Till today
Description
Sun Pharma hasworld-classstate-of-the-artmanufacturingsitesspanning6continentsover45 (API & finisheddose).These
manufacturingunitsarelocatedinIndia,USA, Brazil, Canada,Egypt, Hungary, Israel, Bangladesh,Mexico,Romania,Ireland,
Morocco,Nigeria,SouthAfrica andMalaysia.Sun Pharma unitsare ableto provide best-in-classproductstopatientsacross
150countriesworldwide.
Sun Pharma manufacturingoperationsarefocusedonproducinggenerics,brandedgenerics, specialty,over-the-counter
(OTC)products,anti-retroviral (ARVs), Active PharmaceuticalIngredients(APIs) andintermediatesinthefull rangeof dosage
forms, includingtablets,capsules,injectables,ointments,creamsandliquids. SunPharma alsomanufacture specialtyAPIs,
includingcontrolledsubstances,steroids,peptidesandanti-cancersdrugs.
A widerange of regulatoryagencies likeFDA-USA, EMA-Europe, MHRA-UK, MCC-SouthAfrica,TGA-Australia, ANVISA-
Brazil, WHO-Geneva,BfArM-Germany, KFDA-Koreaand PMDA-Japanroutinelyconductstringentauditsof Sun Pharma
manufacturing sitesforcompliancewithCurrentGoodManufacturingPractices(cGMP)andcertifiedthefacilities.
KeyResponsibilities:
As a GM – Corporate Validation,Sun GlobalOperations
 Leadfor Corporation Validationfunctionsacrossall Sunformulation units.
 Over view of all manufacturingsitesvalidationactivitiesfor compliance.
 Participationinprojectreviewmeetingsforco-ordinationandcompletionofvalidationactivities.
 Trackingofnon-compliances,ifany throughglobalcompliancechecklistacrossallsites.
 GAPassessment,planningandco-ordinationforthe harmonizationofpolicydocuments likeVMP&
sitemasterfile,site validationprocedures and,qualification protocol templates,qualification
proceduresand frequencies acrossallsites.
 Preparationandimplementationofcorporatepolicies/Procedures.
As a CSV specialist
 Leadfor computersystem validationactivities.
 ExperiencedprofessionalinPharmaceuticalandhealthcarecompliancedomain GxP,GAMP5 and21 CFR
part11 requirements.
 Over 11.5 years of experienceinprovidingtacticaldirectionandguidanceforprojectteamsimplementing
Computer Systems fornewor existing GxP systems.
 Developmentof CSV/PLC-relatedSOPs, Guidelines,Standards,TemplatesandTrainingMaterialstothe
agreedtimescalesforGlobalCompliance.
 Handson experiencein GxPimpactassessmentasperISPE guidance,Functional &Quality riskassessment
as per ICHQ9& GAMP5 and Part11 assessmentas part of 21CFR.

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Role:DGM-CQA(Validation) Feb’2015 – Oct’ 2016
Description
Gland PharmaLimited is a globallyrenowned manufacturer of Small Volume Parenterals (SVPs). Gland produces a wide
range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions and ophthalmic
solutions. It is pioneered in Heparin technology in India. It had set up first in India a state-of-the-art Pre-Filled Syringes
(PFS) facilityat Hyderabadin 1998,as wellas the first liquidinjectablefacilityin India accepted byUSFDA. In additionto that
Glandhada dedicated Penemsmanufacturing facility atHyderabad anddedicated oncology facilityat Visakhapatnam.It
serves the pharmaceutical needs of diverse markets worldwide by developing niche products through strong in-house R&D
expertisein.
As a Lead - CQA(Validation)team
 Leadfor CQA(Validation)functionsacrossallformulationandAPI sites.
 Active participantincorporateassessmentaudits.
 Over view of all manufacturingsitesvalidationactivitiesfor compliance.
 Trackingofnon-compliances,ifany throughglobalcompliancechecklistacrossallsites.
 Managedepartmentaltechnicalstaffand communicatewithotherdepartmentsregarding
Validation queries,maintenanceandcompliancewithdepartmentalSOPs.
 GAPassessment,planningandco-ordinationforthe harmonizationofpolicydocuments likeVMP&
sitemasterfile,site validationprocedures and,qualification protocol templates,qualification
procedures and frequencies acrossallsites.
 Preparationandimplementationofcorporatepolicies/Procedures.
As a CSV specialist
 Leadfor computersystem validationactivities.
 ExperiencedprofessionalinPharmaceuticalandhealthcarecompliancedomainwithwideexperiencein
GxP, 21CFRpart11, GAMP5 requirements.
 Over 10 years of experienceinprovidingtacticaldirectionandguidancefor projectteamsimplementing
Computer Systems fornewor existing GxP systems.
 Developmentof CSV-related SOPs, Guidelines,Standards,TemplatesandTrainingMaterialstothe
 Handson experiencein impactassessmentasperISPE guidance,Functional&Quality riskassessment
as per ICHQ9& GAMP5 and Part11 assessmentas part of 21CFR.
As a Trainer
 Responsibleforconductingtrainingprogramsforvalidationteamsof allsites on validationapproach,
cGMPandregulatoryrequirements.
 Developmentof subordinatesandteam buildinginthedepartment.

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Role:DGM-CQA(Validation) Feb’2011 – Feb’ 2014
Description
Hospira healthcare IndiaPvt.Ltd.,located at Parawada,Visakhapatnam issubsidiaryof Hospira.Inc. is the world's leading
provider of injectabledrugsand infusiontechnologies.It is the world's largest producerof generic injectablepharmaceuticals,
manufacturinggenericacute-careandoncologyinjectables,aswellasintegratedinfusiontherapyandmedicationmanagement
systems. Hospira,hasthe themeof makeadifference everyday by positivelyimpactingthelivesof customers&patientsand
deliveringvalue to all of our stakeholders.
As a Lead - QA(Validation)team
 Handledgreenfieldprojectvalidationactivitiesfor aseptic manufacturingblock.
 PreparedValidationMasterPlan for site as per globalandregulatoryrequirements.
 Preparedthe qualificationprotocoltemplatesaspercurrentindustry andregulatoryrequirements.
 Organizedandconductedthevalidationactivitiesas per organizationaltimelines.
 DevelopedandimplementedthevalidationproceduresforcomplyingthecGMP requirement.
 Completedvalidationactivitiesas a team lead for processutilities, processequipmentandlaboratory equipment
/ instruments.
Utilities
 Processutilities- Water system (Processwater system, Purifiedwater, WFI & Puresteam).
 Compressedgases-(Nitrogenand compressedair)asper ISO 8573.
Environmentcontrol and monitoring systems
 Air handling units, Laminar air flow units, Material storage lockers, Dynamic pass boxes, Door interlocking
systems.
Asepticmanufacturing area processequipment
 Autoclave, Vaporized Hydrogen Peroxide system, Vial washing machine, Vial depyrogenation tunnel, Vial filling
machine,Vial sealingmachine,Trayloadingmachines,Lyophilizers,Solutionpreparationtanksand Balances.
Warehouseequipment
 Temperaturemappinginstorageareas,i.e., Walk-in coolers,Quarantine/approvedRM storeand FG store.
 Samplinganddispensingbooths.
 Weighingbalances.

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Laboratoryequipment
 Chemical -Server connectedinstruments(HPLCs,UPLCs, GCsandUVs).
 Chemical -Standalonesystems (pHmeters, conductivitymeters,FTIRs,Ovens, Glasswarewashingm/c
 Microbiology-Autoclaves, Biosafety cabinethoods,Incubators,BET blocks,Refrigerators,Air samplers.
QAequipment
 Stabilitychambers.
 Temperaturemappinginstorageareas,i.e., Control samplesstoragearea,Reserve samplesstoragearea.
As a CSV specialist
 Coordinationandtechnical supportforcomputersystem validationactivities.
 Over 9 years of experienceinprovidingtactical directionand guidanceforprojectteams.
 Implementedthecomputer systemsfor new GxP systems.
 Developedthe of CSV-related SOPs, Guidelines,Standards,TemplatesandTrainingMaterialstothe
 Proficientin impactassessmentasperISPE guidance,GxPassessment,GxPriskassessmentasper
GAMP5,Part 11assessmentas part of 21CFRandQualityRisk Assessment as per ICHguidance.
Handling ofQualityMonitoring System
 Overseen developmentalactivitiesforStandardOperatingProcedures.
 Review of exceptionsandCAPA reportsprior to closure.
 Initiation, review anddispositionof changecontrols.
Audits&compliance
 Handson experienceininternalauditswithreferencetocGMPandsite procedures.
 Active participationinregulatoryauditslike USFDAandfor corporateauditsfor both inaudit
Preparednessandaudits.
As a Trainer
 Conductedvarioustrainingprogramsforvalidationteamson validationapproach,cGMPandregulatory
requirements.

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Role:Sr. Manager -QA(Validation) Jul’2009 – Feb’2011
Description
Plethico PharmaceuticalsLimited,islocatedatKalaria,Indore isaleadingglobalhealthcare/pharmaceuticalcompanywith
a strongemphasisonthe allopathic formulationsincludepain,cough&coldtherapeuticandanti-inflammatoryproducts, herbal
formulations includes a range of cough and cold remedies and medicated lozenges and confectionaries and nutraceuticals
segments comprising of dietary supplements, sports nutrition products, functional foods, vitamins, minerals and weight loss
products.
The company which was established in 1991 and focused on manufacturing and marketing a range of branded generic
pharmaceutical formulations, has rapidly evolved and now engages in the manufacture, marketing and distribution of
pharmaceutical and allied healthcare products in the nutraceuticals and herbal segments in India and internationally.
Domestically,Plethicooperatesinthe segmentsof Sports Nutrition, ConfectionaryandOTC,inIndia.
As a Lead - QA(Validation)team
 PeriodicallyupdatedtheValidationMasterPlan
 PreparedCleaningValidationMasterPlan
 Successfullycompletedvalidationactivitiesfor
Asepticprocessarea
 Autoclaves, Vial washing machines, Vial depyrogenation tunnels, Vial filling machines, Vial sealing machines,
Externalvial washingmachines,Lyophilizers,Labeling machines,Balances.
Tabletand capsulearea
 Sifters, Octagonalblenders,Fluidbeddriers,RapidMixerGranulators,TabletcompressionandCoatingmachines,
Capsulefillingmachines,Blisterpacking machines.
Ayurvedicand allopathicliquidfilling area
 Bulk solutionpreparationtanks,Liquidfillingpumps, Labeling machines.
Candypreparation area
 Bulkcandysolutionpreparationtanks,CandyRollingmachine,Candycuttinganddryingmachine,Candypacking
machine,Candybulk packingmachines.
Warehouseequipment
 Temperaturemappinginstoragearea(Quarantine&approvedRM storage), Walk-incoolers,FG storage.

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Laboratoryequipment
 Chemical -Standalonesystems (pHmeters, conductivitymeters,FTIRs,Ovens, Glasswarewashingm/c.
 Microbiology-Autoclaves, Biosafety cabinethoods,Incubators,BET blocks,Refrigerators,Air samplers.
QAequipment
 Temperaturemappinginstorageareas(Controlsamplesstoragearea,Reserve samplesstoragearea).
Asepticmediafillvalidations
Cleaning verification for Injections,Tablets&Capsules
As a CSV specialist
 Coordinatedandgiventechnicalsupportforcomputersystem validationactivities.
 Overall5 years of experienceinprovidingtactical directionandguidanceforprojectteamsimplemented
the computersystemsfor new andexisting GxP systems.
 Developedthe of CSV-related SOPs, Guidelines,Standards,TemplatesandTrainingMaterialstothe
 Proficientin impactassessmentasperISPE guidance,GxPassessment,GxPriskassessmentasper
GAMP5,Part 11assessmentas part of 21CFRandQualityRisk Assessment as per ICHguidance.
 Review of marketcomplaintsandhandlingofmarketcomplaintrecords.
 Review of validationdocumentsforcompliance.
Auditsand compliance
 Actively participatedinregulatoryauditslike MHRA, Uganda,Ethiopia,Zimbabweetc.,
As a Trainer
requirements.

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Role:MANAGER -QA (Validation) May’2003 – Jul’ 2009
Description
Orchid Chemicals&PharmaceuticalsLtd,Chennai hassetup Orchid healthcare,a100%EOU(exportorientedunit) inthe
SIPCOT Industrial Estate, Irungattukottai, near Sriperumbudur, Chennai for manufacture of cephalosporin antibiotics,
injections,tablets,capsules,drysyrups andNPNCproducts(Constructedinseparateblock).Orchidhasapprovedbyregulatory
agencies like USFDA, MHRA. Thecompanyhas signed an exclusive pact with Apotex to market Cephalosporin injections in
USA, signed an agreementwithPar Pharmaceuticalsto marketoral cephalosporinformulationsinUS market.It has eentered
into a marketingagreementwithSTADAPharmaceuticals(USA)for NPNCproducts.
KeyResponsibilities
As a In charge -QA(Validation)team
 Preparedthe ValidationMasterPlan as perregulatoryrequirements..
 Preparedthe CleaningValidationMasterPlan.
 Preparedthe of validationtimelines,schedulesincoordinationwithprojectdepartment.
 Successfullycompletedvalidationactivitiesfor
Utilities
 Plant utilities(DG sets, PCCs, MCCs,Boilers, Chillers,Hot watersystems)
 Processutilities- Water system (Soft water plant, Purifiedwater, WFI and Puresteam)as perISPE
 Compressedgases(Nitrogenandcompressedair)as per ISO 8573
Environmental control and monitoring systems
 Air handlingunits,Laminarairflowunits, Materialstoragelockers,Dynamic passboxes
 BuildingManagementSystem,
Processequipment
 Autoclave, Vial washingmachine,Vialdepyrogenationtunnel,Vial fillingmachine,Vial sealing machine
Externalvial washingmachine,Lyophilizers,Labeling machine,Balances.
 Sifters, Octagonalblenders,Fluidbeddriers,RapidMixer Granulators,TabletcompressionandCoating
machines,Capsulefillingmachines,Bulkpackingline,Blisterpackingmachine.
Warehouseequipment
 Temperaturemappinginstorageareas(QuarantineandapprovedRM storage),Walk-in coolers,FG storage

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Laboratoryequipment
 Chemical -Server connectedinstruments(HPLC,GC, UV).
 Chemical -Standalonesystems (pHmeters, conductivitymeters,FTIRs,Ovens, Glasswarewashing machine.
 Microbiology–Autoclave, Biosafety cabinethoods,Incubators,BET blocks,Refrigerators,Air samplers.
QA equipment
 Temperaturemappinginstorageareas(Controlsamplesstoragearea,Reserve samplesstoragearea).
Asepticmediafill validations
Cleaning verificationand validationsforregularproduction sizebatchesof
 Cephalosporin Injections,Tablets,CapsulesandDrypowders.
Processvalidationsforregularproduction sizebatchesof
Transportvalidationsfor
 Overseen developmental activitiesforStandardOperatingProcedures.
 Review of marketcomplaintsandhandlingofmarketcomplaintrecords.
Auditsand compliance
 Handson experienceininternalauditswithreferencetocGMPandsite procedures.
 Active participationinregulatoryauditslike USFDA, MHRAetc., both in auditpreparednessandaudits.
As a Trainer
Requirements.
Certifications
 Having certificationasqualifiedauditor.

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Role:Executive(Production) Mar’1997 – May’ 2003
Description
Gland PharmaLimited is a globallyrenowned manufacturer of Small Volume Parenterals (SVPs). Gland produces a wide
range of injections, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions and ophthalmic
solutions. It is pioneered in Heparin technology in India. It had set up first in India a state-of-the-art Pre-Filled Syringes
(PFS) facilityat Hyderabadin 1998,as wellas the first liquidinjectablefacilityin India accepted byUSFDA. In additionto that
Glandhada dedicated Penemsmanufacturing facility atHyderabad anddedicated oncology facilityat Visakhapatnam.It
serves the pharmaceutical needs of diverse markets worldwide by developing niche products through strong in-house R&D
expertise in.
As a batch compounding chemist
Handson experienceonbatchmanufacturingprocessforvarious productslike
 Gentamycin80mg/mLinj.,Garamycin20mg/mLInj.,and80mg/mLInj., for M/s. Fulford,Mumbai.
 Sofracort, Soframycin andSofradexeye dropsfor M/s. Aventis pharma,Mumbai.
 DecadoninjectionforM/s.WockhardtLtd., Mumbai.
 Tidigesic forM/s.TDPL,Chennaiand
 Heparin5000IU/mLand10000IU/mLinjections,Amikacinsulphate250mg/mLand500mg/mLinjections
for M/s. GlandPharmaLimited.
As a Production line-incharge
 ResponsibleforPreparation,maintenanceandcomplianceofcGMPrecords.
 Performedperiodic integritytestingof 0.22µ filters at point of use.
 Involved in lineclearanceactivitiesforvarious in-processactivities.
 Monitoredtheactivitieslike Non-viableairborneparticlecount,Fumigation,Room differentialpressures,
Passive air samplingbysettle plateexposuresandActive air samplingbyairsamplers,etc.,
 Review of batchmanufacturingandbatchpackingrecordspriortobatchdispatch.
 Batchdispensing.
 Componentpreparation.
 Autoclave preparedness.
 Vial depacking.
 Vial washing.
 Tunnelsterilizer& depyrogenation.
 Vial fillingand stoppering.
 Vial sealing.
 Vial opticaltesting.
 Vial labeling andpacking line.

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As a Trainer
 Conductedemployeestrainingprogrammefornewemployees.
Qualificationactivities
 QualificationprotocolspreparedforprocessequipmentatAmeerpet unitas part of retrospective
qualificationprogramme.
 Involved in processequipmentandutilitiesqualificationfornewgreenfield projectat D.P. Pally, unit.
 Participated ingowningvalidationandaseptic mediafillvalidations.
Personnel Details
Date of birth : 1st January1969
Maritalstatus : Married
Nationality : Indian
Languagesknown : English - Read,write and speak
Hindi - Read,write andspeak
Telugu - Read,write and speak
Tamil - Read, write andspeak
Currentaddress : Flat No.: B/1, HakimiCo-operatingsociety,
Liliya Nagar,Goregaon(West),
Mumbai,Maharashtra –400043,
India
Permanentaddress : FlatNo. 301,
NarmadaBlock,
OceanGreenApartments,
SaimonNagar,
Kurmannapalem,Visakhapatnam -500046,
India
Computerskills
Handson experienceon : MSOffice
: ComputerSystem Validation
Declaration
I dohereby declarethatthe above informationiscorrectbestof myknowledge.
..... V L KANTHACHARIPUSAPATI

Kanth CV (14..01.2017)

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