SeekingchallengingassignmentsinQualityAssurancewithagrowth-orientedorganizationof
reputeinPharmaceuticalindustry
PROFILESUMMARY
M.Sc.(OrganicChemistry)with3yearsand5monthsofexperiencein:
~QualityAssurance ~DocumentControl ~GMP
Compliance ~CAPAManagement ~QualityManagementSystem
(QMS)~DATAIntegrity
ï· PresentIam workingas“SeniorOfficer–QualityAssurancedepartment”inSequentGroupof
AlivirasciencesPrivateLimitedbelongstoParawada,inAP.FromJan-2019topresent.
ï· Previouslyworkedas“Associate–QualityAssurancedepartment”inDr.Reddy’slaboratories
limited.BelongstoPydibheemavaram,inAP.FromJan-2016toDec2018
Jobprofile
ï§ Reviewingofproposedchangecontrolsandclosureresponsibilities.
ï§ Handlingofdeviations,generaldeviationsandclosureresponsibilities
ï§ TrackingalltheincidentsandCAPAasperdepartmentwise
ï§ VerificationofCAPAimplementationandclosureofCAPAgivenbyuserdepartmentforQA
notification
ï§ ReviewofMasterbatchmanufacturingrecords
ï§ Assessingandreviewingbatchmanufacturingrecords,batchcleaningrecordsandbat
ch
packingrecordsonline
ï§ Caringoutverificationofareadocumentationlikebatchrecords,logbooks,statuslabelingetc.
ï§ Managingqualityacrossrawmaterials,facility&Buildingmaintenance,People,Documentation
&RecordsinvariousfunctionaldepartmentsaspercGMPstandards
ï§ CoordinatingforcompletionofvariousCustomeraudits
ï§ ImpartingtrainingtoshopflooremployeesoncGMP,SOPs
ï§ EnsuringtheimplementationofcGMPinalldepartments
ï§ Performinglineclearanceactivities
ï§ EnsuringGMPonShopfloorandallRelatedAreas
ï§ PerformingIPQAactivities
ï§ Performingandmonitoringdocumentanddatacontrolofallcontrolleddocuments(Issuance,
retrieval,archival,anddistribution)
Highlights:
ï§ TimelyrespondedtovariousdepartmentrequeststofulfillthecGMPrequirements
ï§ CoordinatingforcompletionofvariousregulatoryauditssuchasUSFDA,WHO,TGA
ï§ ActivelyParticipatedasaTeam MemberinQCP(QualityCommunicationProgram)tocreate
awarenessonDataIntegrity&Reliability
ACADEMICDETAILS
Post-GraduationM.Sc.(OrganicChemistry)fromAndhraUniversity.
Graduation B.Sc.(Chemistry)fromBRBMDegreeCollegeVishakap