Sheshanka Andhe

Director, Global Regulatory Affairs & Compliance at CellCarta

Role
Director, Global Regulatory Affairs & Compliance at CellCarta
Location
Naperville, IL, US
LinkedIn followers
500 followers

About Sheshanka Andhe

I’m a regulatory affairs and compliance leader with deep experience building and…

Experience

  1. Director, Global Regulatory Affairs & Compliance

    CellCarta

    Jan 2021 — Present · Naperville, IL, US

    Responsible for Quality Management System compliance, Supplier quality, process improvements. Electronic Data Management System Deployment including configuration, process development,end user training, Validation deliverables and end user support for the following Modules:1. Document Management2. Training Management3. CAPA/Events4. Deviations5. Non-Conformance6. Change Control7. Supplier Management8. Audit9. Risk Management10. Registrations & Design history file11. Customer complaints12. eMDR/Vigilance reporting

Education

  • New Jersey Institute of Technology

    Master's degree

  • Kakatiya University

    Bachelor's degree

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Sheshanka Andhe — Director, Global Regulatory Affairs & Compliance at CellCarta in Naperville, IL, US | Unifers