Danyu Xu

Senior Validation Consultant @Medical Engineering Consultants (MEC)

San Francisco, CA, US

EMAILS

[email protected]

MOBILE NUMBERS

+13•••••••22

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WORK HISTORY

Mar 2023 — Present

Senior Validation Consultant @Medical Engineering Consultants (MEC)

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EDUCATION

N/A

Southeastern University (Washington, D.C.)

MS, Computer

N/A

Eastern Illinois University

MS, Chemistry

N/A

Jilin University

BS, chemistry

SKILLS

AutomationIsoPharmaceutical IndustrySopLife SciencesCalibrationComplianceDocumentationIso 13485Technology TransferCgmpQuality SystemQuality SystemsV&VFmeaDocument ManagementQuality ControlPharmaceuticalsRegulatory RequirementsGmpTestingMedical Device R&DRisk ManagementLimsComputer System ValidationRequirements AnalysisValidationSoftware Quality AssuranceChange ControlGlpSoftware ValidationQuality AssuranceMedical Devices21 Cfr Part 11Verification and Validation (V&V)GampHplcU.s. Title 21 Cfr Part 11 RegulationQcData Management

ABOUT DANYU XU

A seasoned validation professional well versed with various aspects of validation in life science arena such as pharmaceutical/biotech/medical device/nutraceuticals industries. Expansive knowledge and experience in all phases of software lifecyle including generating, reviewing and executing various validation deliverables including Validation Plans, GxP Assessments, User Requirements, System Impact Assessments, Functional Risk Assessments, 21 cfr Part 11 and/or Annex 11 Assessments, IQ/OQ/PQ protocol, Function Requirement Specifications, Configurration Specifications, System Design Specifications, Work Instructions/SOP, Requirement Traceability Matrices, Data Migration, Periodic Review and Decommissioning activities etc.

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