PHARMACEUTICAL (QUALITY ) PROFESSIONAL

1. 1
PRAMESH KOTHARI
 Address: C-1203 Orchid Divine,
South Bopal, Ahmedabad,India
 Phone:+91 9327726099
 E-mail:pramesh_kothari@rediffmail.com
Summary
 An eminently successful Quality Control professional with more than 27
years of comprehensive analytical expertise in complex formulations
including Aerosol, Nasal, MDIs, DPIs, Injectable, solid-orals, transdermal
in Pharmaceutical industry.
 More than 7 years of experience as Director/General manager leading
the QC laboratories of growing multinational pharmaceutical
companies.
 Skilled in developing and enhancing Quality Control standards,
Compliance, Method Validations and Transfers, Stability and Timely
releases.
 Adept at developing, enhancing, monitoring sustained quality practices
compliant with global compliance and global regulatory standards.
 Well-versed in developing and enhancing Quality Control standards;
with regulatory guidelines and its implementation.
 Competent with conducting quality audits for on-site labs, contract labs,
API, and formulation manufacturing.
 Adroit at managing multiple labs and its functions.
 Skilled at developing new laboratories and compliance establishment.
 Able to cultivate strategic relationships with employees, peers,
managers, directors, and stakeholders.
 Expert in writing technical reports like analytical method development,
method transfer, deviation, change controls, audit compliance.
 Skilled at providing technical support for RA for CMC query of ANDA
products.
 Focused and methodical Director offering expertise in testing and
quality monitoring of various dosage forms including Solid/Oral,
injectables, soft gelatin, MDI/DPI. Demonstrated success in upholding
standards, monitoring safety, and promoting excellence in all areas of
quality. Experienced in producing detailed reports and maintaining
thorough records.
Key Skills
 Have expertise and experience in all the latest tools and techniques of
laboratory.
 Analytical expertise for a sophisticated analyticaltechnique like HPLC,
GC, Dissolution, Spreytech,Breath simulator, NGI, Cascade Impactor, etc.
 Established the laboratory for complex formulation analysis.
 Have specialization and exposure of aerosol / Nasal / MDIs / DPIs /
Injectable / products analysis / product characterization and BA/BE
studies.

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 Have great analytical / investigation skills for the root cause identification
for specializing formulations like Tablets, Hard gelatin capsules, soft
gelatin capsules, Aerosols, Nasal, Transdermal, Injectable, Medical
devices.
 Have excellent management skills and mentored to develop skilled
analysts, executives, and managers.
 Excellent communication and presentation skills.
 Have successfully transferred and validated many analytical methods for
complex formulations like Tablet, capsule, Injection / Nasal / Aerosols /
Nebulizer / MDIs / DPIs.
 Trend evaluation of OOS / OOT / Laboratory Incidences to derive the
CAPA to reduce the errors.
Other competencies
 Designing Service Level Agreement
 GLP
 Conducting Timely Internal Audits
 Root Cause Analysis and CAPA
 Trending and Analytics
 Troubleshooting
 Technology Transfers
 TRACKWISE
 Analytical Method Validation
 Regulatory Impact and Risk Assessment of the Proposed Changes
 LIMS
 Management skills
 Mentoring
 Project planning
 Strong work ethic
 Organization
 Budget preparation
 Employee training
 Composing Corporate policies and procedures
 Recruiting and Hiring
 Worked with MCKINSEY for Quality culture improvement and productivity
enhancement
Education
 Master of Science inChemistry- (Madurai Kamaraj University)
 Bachelor of Science- (GujaratUniversity)
Professional WorkExperience (Startingwith current position)
Cadila Healthcare LTD. (SEZ), India
Plant Quality Control Head (From October’2020)

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Summary:
The plant is a new green-fieldprojectandis still under construction.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
 Monitoringof laboratoryestablishmentactivities.
 Review andapprove of instrument/equipmentURS.
 Responsible forpreparationof the QCCapex.
 Reviewandapprove of qualificationprotocols.
 Hiringqualityprofessionals
 Reportingtothe SeniorVice President(ClusterHeadof the ZydusGroup)
 Involved inmethod developmentof PATforblendinguniformity testing.
 Responsible forestablishmentof the new laboratory.
NesherPharmaceuticalsLimited,USA
Director Quality Control (Sept’2018 to Sept’2020)
SUMMARY
Directing the managers for daily operations of laboratory and stability to maintain high degree of
performance, compliance, and efficiency. Also, responsible for monitoring release targets and
stability oversight. Overseeing and investigating OOS, OOT, deviations, Change controls, CAPA
and laboratory incidents. Working with SME auditors like LACHMAN for compliance
improvements. Composing QC budget and overlooking resource management. Managing FDA
audits and compliance of GMP and PAI audits. Responsible for interviewing potential candidates
and collaborating with HR for hiring QC professionals. Responsible for timely launch of new
products. Overseeing the training needs to develop skilled Quality workforce. Actively
participating in the business and compliance scheduled meetings. Designing more efficient
processes to improve Quality and efficiency.
ESSENTIAL DUTIES AND RESPONSIBILITIES
 Providingcomprehensiveformal andinformal leadershiptopromote apositive work
environmentand communicatesoverall businessexpectationstothe plantworking
groups.
 Directingthe dailyoperationsof the QCLab to maintainahighdegree of performance,
cGMP/EU/FDA compliance, efficiency, andoutputof reliable/accurate data.
 Directingthe reviewandapproval of specificationsandtestmethodsforfinishedgoods
and raw materialsmethodsinan accurate,timelymanner.
 Ensuringthe transferof finishedgoodsandraw material testmethodsoccursina timely
mannerfromR&D or anyother sources.
 Determininglaboratory capacityandresourcesneededtomaintainQCturnaroundtime
for finishedgoods andrawmaterials.
 Reviewingandapprovesinvestigationsinatimelymannertoensure adequacy of
investigations.
 Ensuringall analysts/microbiologistsare properlytrainedandtrainingismaintainedat
the highestlevelforall personnel.
 Reviewingandensurestimelyrevisionsandimplementationof compendialchangesfor
monograph.ReviewingandupdatesSOPs asperregulatoryguidance.
 Participatingincompany meetingsandcommitteesasneededorrequired forbusiness
and compliance needs.
 Evaluatingequipmentneedsforthe laboratoryasnecessary,includingautomated
systemsthatmay be requiredtomaintainperformance levelsforreproducible and

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reliable testresults.
 Designingmore efficientprocesses toimprove the efficiency.
 Workingcross-functionallyfordeviationsandsystemimprovement.
Cadila Healthcare Limited(Zydus),Ahmedabad, India
Site Quality Control Head (General Manager,Since June’2015 to Sept’2018)
SUMMARY
Directing20 managersand more than 300 QualityControl professionalsand managing7QC
laboratories. Developingthe Qualityculture byQUESTmovement. Responsible forreviewing
and approvingthe documentsincludingSOPs,OOS,OOT,OOC,Lab incidences,Change
Controls,CAPAsanddeviations.WorkwithSMEauditorslike 5W,LACHMAN for compliance
improvements. Tosupportinvestigationteamforhypothesisplanandrootcause analysisof
OOS/OOT/OOCandlaboratoryincidences.Responsible forinstallingandmaintainingCFR
complaintinstruments.Accountable toupgrade qualitysystem aspercorporate guidance.
Supportingmangersfortrouble shootingof instrumental andchemical testing. Responsible
for achievingthe release targetandupdate the supplychain.Monitoringandmaintaining
laboratoryexpansesperallottedbudget. Responsiblefortimelycommercializationof ANDA
products.
ESSENTIAL DUTIES AND RESPONSIBILITIES
 Managing 7 laboratory operationsand about 300 employees.
 Managing about20 managersas secondline to maintainQCoperations.
 Monitoringof the GMP compliance of Laboratoryforbusinesscontinuity.
 Implementationof qualitysystemprovidedbycorporate quality.
 Lead QC teamforregulatoryaudits.
 Developthe qualityculturebyQUEST movement.
 Successful auditsof USFDA (Feb’17 & Aug’17) ANSM(May’17), ANVISA,WHO
(2017).
 Successful audit of customers like Blue point, Helm,Sagant
 Successful auditsSMEs like 5WS, Lachman.
 Reviewandapproval of QMS documentslike SOP’s,OOS,OOT,Lab.Incidences,
change controls,CAPA,Deviations.
 Technical supporttoinvestigationteamforthe rootcausesanalysisof OOS/ OOT /
Lab. Incidence.
 AnalysisplanningwithGDSOfor release of raw materialsandfinishedproductsto
achieve the businesstargets.
 Troubleshootingforthe Instrumentaland chemical analysis.
 Developingthe teamforvariousskill levelslike,complexanalysis,review,
investigation,leadershipetc…
 Submissionof ANDA documentsandCMC queryrelatedresponse.
 Budgetingandpurchasinglaboratoryconsumablesandinstruments.
 Initiative toimprovelaboratory productivity,infrastructure.
 Attendingbusinessmeetingsfornew future productsdevelopmentof Aerosols/
Nasal spraysand NDDS.

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Sun Pharmaceuticals Ltd., Vadodara, India
Deputy General Manager- Central Analytical Laboratory (October’2013 – June’2015)
ESSENTIAL DUTIES AND RESPONSIBILITIES
 Holdfull responsibilityforthe timelydeliveryof projectsthroughsuccessful
coordinationof all tasksassociatedwithanalytical testinglike,methodvalidation,
methodtransfer,dissolutionstudies,Aerosolproductanalysis.
 Validatingandtransferringabout500 methods.
 Identifyingtechnical problems/issues,developing solutions, andfullyimplementing
these solutions.
 Providingsupporttothe plantQC forsuccessful transferof methodsand remedialof
methodsonanalytical issue.
 Resource schedulingasperprojecttimelines.
 Complete departmentalKeyPerformance Objectives(KPOs)forall personal and
specificprojects.
 Ensure laboratorycGMP procedures adhered by individuals.
 Continuousdevelopment, update, andstrengthGLPrequirementbyreviewing
regulatoryrequirements,events,deviations,trends,warningletters.
 Continuousimprovingproductivitybyupdatinginstruments,introducingnew
instruments,trendingof analystproductivity, methodsreview.
 Ensure all investigationsare conductedinathoroughand timelymannerin
accordance withprocedures.Supportinvestigatorinsettinginvestigationstrategies.
 To execute,delegateandmonitorthe progress of work daily aboutthe projectplan,
and communicate progresstointernal andexternalstakeholders.
 To ensure adherence toQMS documentclosure/completiontimelines(e.g.CAPA,
CAR,Change Control, Events,Repeatanalysis,OOSetc.).
 Advise andassiststaff introubleshootingmethods andinstrument.
Sun Pharmaceuticals Ltd., Vadodara
Deputy General ManagerCorporate Quality (July2011 - October 2013)
 Responsible forQCrelatedactivitieslike,guideline,directive,CAPA preparation.
 Guidelinepreparationbase onregulatoryguidance,pharmacopoeia,lab.Practices
 Visittoplantfor GLP systemGap analysis.
 Reviewof plantmonthlyreportforOOS/OOC / Repeat/productivity.
 Technical discussionforspecificationfinalizationwithADD/FDD / OS / RA.
 Handlingof analytical issuesnotifybythe plantQCwiththe helpof ADD.
 Monitoringof analytical andstabilityfailuresof plant.
 Visittoplantfor auditpreparation.
 Budgetingof instrumentsandmanpowerfor locationQC.
 Monitoringof LIMS relateddevelopmentactivities.

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UnimedTechnologiesLtd.Baska, Halol (Groupcompany of Sun PharmaceuticalsLtd).
Head Quality (Sr. Manager) (July 2009 – July 2011)
 Responsible forQualitysystemsinplant.
 Responsible forsetting upthe laboratoryforthe regulatoryenvironment,byre-
arrangementof resources,training, teamwork,skill development.
 Responsible forstreamliningthe laboratoryactivities.
 Handlingof OOS/OOC/Repeatanalysisanddeviations.
 Reviewandapproval of change control.
 Developthe skilledpersonforall sectionsof lab.Like raw-material,final products,
stability,review.
 Set up the method validationlaboratory to support the ANDA registrationof other
location.
 Implementationof qualitysystemprovidedby CQ.
 Pharmacopoeial change evaluationforotherlocations.
Sun Pharmaceuticals Limited,India
Laboratory In charge (Officer– Sr. Manager) (Mar 1992 – July 2009)
 Responsible forthe laboratoryoperation.
 Worked with representative of Eli Lilly & Co. (USA) for Insulin products for analysis
and failure investigation.
 Monitoringof the GMP compliance withinthe Laboratoryasper the requirement.
 Reportand investigateoutof specificationsandrepeatanalysis.
 Delegate andmonitorthe progressof workdailyforbatch release.
 Reviewandapproval of SOP’s,specifications, protocols, andreports.
 Troubleshootingtoanalystforthe Instrumental andAssayproblems.
 Setup the laboratoryfor the regulatoryenvironment,training,teamwork,skill
development.
 Develop the skilledpersonforall sectionsof lab.Like raw-material, final products,
stability,review.
 Timelysubmissionof ANDA documentsandCMCqueryrelatedresponse.
 AnalysisplanningwithPPCfortimelyrelease of material.
 Implementationof qualitysystemprovidedbyCQ.
 Instrumentqualificationreview andapproval.
 Purchasinglaboratoryconsumablesandinstruments.
 Budgetingof laboratoryitems.
 Handlingof OOS/OOC/Repeatanalysisanddeviations.
 Reviewandapproval of change control.
 Improve productivityof analyst.
 Lead QC teamforregulatoryaudits.

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SelectedAchievements
 Successfullyledand clearedQC for USFDA Auditresultedas VAI 2 timesat Nesher.
 SuccessfullyclearedUS-FDA(3 times),MHRA, ANVISA,Brazil audit leadingQC
team at CadilaHealthcare Ltd (Zydus).
 Three consecutive USFDAaudits clearedwithout any 483 at Zydus Cadila.
 Have successfullymanagedmultiple laboratoriesconsistingof about 300
employeesatCadila Healthcare Ltd (Zydus).
 SuccessfullyclearedUSFDAaudit by supporting manufacturingsite as Corporate
Quality representative atSUN Halol,SUN Dadra, SUNPanoli and SUN
Ahmednagar unit.
 SuccessfullyclearedUS-FDA(4 times),MHRA (3 times),ANVISA,Brazil audit
leadingQC team at Sun PharmaceuticalsLtd, Halol.
 Have validatedmore than 500 methodsfor ANDA and DMF products undermy
supervision.
 Resolvedanalytical issue at Bodycote laboratory, UnitedKingdomand saved
batches worth of 20 millionUSD
 Honored withthe Best mentor award by Quest.