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| Job Location | Indore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Recruitment Services |
| Functional Area | Quality (QA-QC),Testing |
| EmploymentType | Full-time |
manager- quality assurance in indoreJob Description Details:QA,AsstManager Assumeresponsibilitiesas ManagementRepresentative inimplementation & maintenanceof QualityManagementSystem (ISO13485:2016) inthe organization Documentation, implementationandimprovementofGMP,CEmarking,product regulatory complianceindifferentcountriesPreparationof product,rawmaterialandpackingmaterial specifications,quality plans,samplingstandards,testprocedures.ResponsibleforcarryingoutValidationactivities (DQ,IQ,OQ,PQorvarious equipment) & trainingtheconcernedpersonnel.Approvalauthorityforin-process qualitycontrolandfinalproductrelease.Controlofproductnon-conformity,analysis,correctiveactionanddisposalof complaints.ControlofmonitoringandmeasurementdevicesandrelatedcalibrationactivitiesAnalysisofcustomer/endusercomplaints,correctiveaction&disposal. AdditionalResponsibilities:o CoordinationofHRDactivitiesincludingtrainingneed assessment,training andmaintainingpersonnelrecordso ProvidesupporttoQAHead forcompetencedeterminationo SubmissionofstatutoryreturnsrelatingtoHRthroughCAOo MaintainingHRrecords Past Experience: BSc/Msc inBiochemistryorrelatedsubject ispreferredMinimum 5 yearsexperienceasaQualityAssuranceMiddle/Upperlevel professionalKnowledgeofISO13485:2016 isrequiredKnowledgeofCE,USFDAisabonusKnowledgeofETOsterilizationprocessisabonusImportantSoftwareSkills: AdvancedMSWord andExcel,writtenEnglish Reporting: ReportstoQAHead(alsoVPOperations) skillsquality, quality assurance, Quality Engineer, ISO13485:2016, quality manager, quality executive qualificationB.E/B.Tech, B.Sc, MS/M.Sc(Science),
Keyskills :
quality assurancebsctraininganalysisassuranceregulatoryGxPChange ControlQuality AuditingCorrectivePreventive ActionComputer System ValidationSoftware Quality AssuranceVerificationValidation