Elena Mack

SaniSure

Philadelphia, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Present

@SaniSure

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SKILLS

ManufacturingIso 13485GlpMedical DevicesCapaQuality SystemV&VBiotechnologyDossier PreparationIvddBioburdenCross-Functional Team LeadershipDesign ControlSupplier QualityIso 14971Project PlanningChange ControlRegulatory AffairsLifesciencesQuality ControlGmpSterility AssuranceValidationGlobal Regulatory CompliancePharmaceutical MicrobiologyFda GmpLimsComputer System ValidationCalibrationTrackwiseClass Iii Medical DevicesPharmaceutical IndustrySopFda21 Cfr Part 11Quality AssuranceCleaning ValidationEnvironmental MicrobiologySafety Management SystemsRegulatory Submissions

ABOUT ELENA MACK

Accomplished Quality Leader with years of progressive leadership in the pharmaceutical…

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