AMITKUMAR Vasava
Qa at Adroit Pharmachem Pvt. Ltd.- Claim this Profile
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Bio
Experience
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Adroit Pharmachem Pvt. Ltd.
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India
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Qa
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Feb 2021 - Present
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Officer
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Feb 2021 - Oct 2023
Samplingoffinishedproduct,preparationofretainssample,processvalidationsample and maintain of its record.Responsibleforprocessvalidation,cleaningvalidation,Equipmentqualification.Prepare Validation Protocol And Review of Filled Validation Protocol. Review Process Validation and Equipment Qualification Related Documents.ShallhandleInternalaudit,externalaudit,regulatoryauditparticipant,compliance, monitoring.IssuanceofBMPRtoproductionandreviewofcompletedBMPRs.Issuanceofprotocolforrawmaterial,Packagingmaterials,In-process,intermediate& finished product for analysis. Quality Control Dept which included analytical data review, verification and compliance.Shalloversightinproductiondepartmentwhichincludedlogbooksverification,filled BMR review, verification and complianceReviewofthestability/Holdtimestudyprotocolsandreportoffinishedproducts.Lineclearancefordispensingactivity,manufacturingandpackingactivity.PreparationofAnnualProductQualityReview.asIT-administratorinGXPsoftware’s,AnalyticalinstrumentsandPLC/HMI. Thisshall include,Useraccountmanagementascreation,modificationandeactivation.AssistinInternalAuditandensuretheverificationofcompliances Show less
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RADIANT PARENTERALS LIMITED
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Pharmaceutical Manufacturing
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1 - 100 Employee
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QA Officer
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Sep 2020 - Oct 2021
Line-clearanceandverifyOfManufacturingprocessandactivity. Line-clearanceofPackagingi.e.Labeling,Blisteretc. IssueBMR&BPR. DailyformatissueChecking&reviewofDailyFormatsaswellasOperation&Cleaning Formats of all Machinery regarding. ReceivingRM/PMfromstoredepartment. Coordinationwithstoreandotherconcerndepartment Line-clearanceandverifyOfManufacturingprocessandactivity. Line-clearanceofPackagingi.e.Labeling,Blisteretc. IssueBMR&BPR. DailyformatissueChecking&reviewofDailyFormatsaswellasOperation&Cleaning Formats of all Machinery regarding. ReceivingRM/PMfromstoredepartment. Coordinationwithstoreandotherconcerndepartment
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Education
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Gujarat University