Tatiana Ungureanu

Senior Validation Specialist Qa Qc Compliance Consultant @Merck

Raleigh, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2015 — Present

Senior Validation Specialist Qa Qc Compliance Consultant @Merck

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Raleigh-Durham, NC, US

Responsible for CAPA/QA-QC Compliance audit investigations for Merck, Durham NCResponsible for process validation protocol generation and execution for process mixing vessels and homogenizers for IKA Works, Wilmington, NCResponsible with the Computer Validation Report for Building Management System at KBI Biopharma; Generate SOPs and PMs for BMS System.Responsible for Validation Protocol and Reports generation and execution for numerous environmental chambers, autoclaves, cold storage environments for Qualitest Pharmaceuticals in Huntsville, AL

SKILLS

GampV&VQuality SystemQuality ControlBiopharmaceuticalsSoftware DocumentationQuality AssurancePharmaceutical IndustryChange ControlFdaTechnology TransferRegulatory AffairsU.s. Food and Drug Administration (Fda)Quality AuditingGlpFda GmpSopMedical DevicesBiotechnologyCapa

ABOUT TATIANA UNGUREANU

Deviation Management Author at Merck

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Tatiana Ungureanu — Senior Validation Specialist Qa Qc Compliance Consultant at Merck in Raleigh, NC, US | Unifers