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Deborah Drew

President @Govmojo, Inc

Grafton, MA, US
EMAILS
[email protected]
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Dec 2017 — Present

President @Govmojo, Inc

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Principle consultant providing validation engineering and project management contract services. Recognized as a leading expert on autoclave usage and the instructor of the PDA’s course on Technical Report No. 1 (2007) Revision, Validation of Moist Heat Sterilization Process: Cycle Design, Development, Qualification and Ongoing Control. • Full Spectrum Validation Support (IQ / OQ / PQ / Process Validation) • Small and large molecule formulation • Sterile and non-sterile product presentations • Shipping, Facilities and Utilities • Training and employee development activities

SKILLS

StrategyStrategic PlanningRegulatory AffairsCapaCleaning ValidationIso 13485Computer System ValidationNonprofit OrganizationsRegulatory RequirementsV&VProcess EngineeringSterilizationCalibrationGmpLifesciencesQuality ControlQuality AuditingManagementSoftware DocumentationProject ManagementSopProgram ManagementValidationRegulatory SubmissionsFda GmpBiotechnologyContinuous ImprovementDesign ControlPublic SpeakingQuality ManagementHuman Resource PlanningCross-Functional Team LeadershipDesign of ExperimentsRoot Cause AnalysisQuality AssuranceSix SigmaProcess ImprovementTechnology TransferLeadershipBiopharmaceuticals

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