Nathalie Gaudefroy

FAQ About Nathalie Gaudefroy

• What is Nathalie Gaudefroy's address?

  Nathalie Gaudefroy is located at
  Encinitas, Encinitas, United States

• What is Nathalie Gaudefroy's job title?

  Nathalie Gaudefroy is a
  Biotechnology professional with a track record creating documentation including but not limited to the following: -IQ, OQ, PQ validation documents. -Cleaning validation documents and laboratory reports. -Validation Reports. -Validation deviations. -Trainings for over 300 Manufacturing personnel on validation concepts, Process Performance Qualification (PPQ) training, validation of new products & validation execution strategies using ValGenesis software applications. -Initiated Non Conformances (NCR) and CAPA documentation. -Created SOP, Work Instructions, Quick Reference Guides. -Developed Troubleshooting guides for software and systems. -Created checklists for easy navigation through SAP PLM -Created and revised Instrument Manuals. -Developed and revised Equipment specifications. -Initiated Calibration documents. -Initiated and revised System Software documentation to correct compliance violations. -Created improvements in LIMS software to maintain compliance with FDA regulations and ISO Part 11 compliance. -Created LIMS reports to review data and ensure compliance to ISO 13485 standards. -Led training of OJTs on audit findings and provides solutions to close compliance gaps. -Created Training storyboards & Training presentations on Manufacturing laboratory gowning procedures. -Collaborated with stakeholders to develop Product Specification documentation to support a 510k. -Created Product Marketing material and generated 22% increase in sales by running promotions of products. -Initiated and revised Design Control Documents to support a 510k. Efficiently manages multiple projects, brings a Quality mindset to train new Technical Writers, develops documentation for manufacturing and validation of systems, processes, as well as software and facilitates collaboration with stakeholders to drive projects to completion on time. Open to new challenges and opportunities. Nucleus Biologics

• What industry does Nathalie Gaudefroy currently work in?

  Nathalie Gaudefroy currently works in the
  Nucleus Biologics

• What is Nathalie Gaudefroy's area of expertise?

  Nathalie Gaudefroy specializes in
  Biotechnology professional with a track record creating documentation including but not limited to the following: -IQ, OQ, PQ validation documents. -Cleaning validation documents and laboratory reports. -Validation Reports. -Validation deviations. -Trainings for over 300 Manufacturing personnel on validation concepts, Process Performance Qualification (PPQ) training, validation of new products & validation execution strategies using ValGenesis software applications. -Initiated Non Conformances (NCR) and CAPA documentation. -Created SOP, Work Instructions, Quick Reference Guides. -Developed Troubleshooting guides for software and systems. -Created checklists for easy navigation through SAP PLM -Created and revised Instrument Manuals. -Developed and revised Equipment specifications. -Initiated Calibration documents. -Initiated and revised System Software documentation to correct compliance violations. -Created improvements in LIMS software to maintain compliance with FDA regulations and ISO Part 11 compliance. -Created LIMS reports to review data and ensure compliance to ISO 13485 standards. -Led training of OJTs on audit findings and provides solutions to close compliance gaps. -Created Training storyboards & Training presentations on Manufacturing laboratory gowning procedures. -Collaborated with stakeholders to develop Product Specification documentation to support a 510k. -Created Product Marketing material and generated 22% increase in sales by running promotions of products. -Initiated and revised Design Control Documents to support a 510k. Efficiently manages multiple projects, brings a Quality mindset to train new Technical Writers, develops documentation for manufacturing and validation of systems, processes, as well as software and facilitates collaboration with stakeholders to drive projects to completion on time. Open to new challenges and opportunities.

• Which languages does Nathalie Gaudefroy speak? 

  Nathalie Gaudefroy speaks the following languages:
  No languages available.

• Which industries has Nathalie Gaudefroy previously worked in?   

  Nathalie Gaudefroy has prior experience in the following industries:
  Pina Publishing , Illumina , Illumina , Illumina , Alere , Genoptix , Genmark Diagnostics , Genentech , Dako

• What is Nathalie Gaudefroy’s work experience?  

  Nathalie Gaudefroy has the following professional experience:
  Nucleus Biologics , Pina Publishing , Illumina , Illumina , Illumina , Alere , Genoptix , Genmark Diagnostics , Genentech , Dako .

• How can I find Nathalie Gaudefroy on LinkedIn?  

  You can view Nathalie Gaudefroy’s
  LinkedIn profile at LinkedIn URL.

• What are Nathalie Gaudefroy’s work email addresses?  

  Nathalie Gaudefroy’s work email addresses are
  [email protected] .

• What company does Nathalie Gaudefroy work for?  

  Nathalie Gaudefroy works at
  Nucleus Biologics