Irwin Hirsh

Senior Process Consultant

Irwin Hirsh has nearly 30 years of pharma experience with a background in CMC encompassing discovery, development, manufacturing, quality systems, QRM, and process validation. He regularly supports projects as a QbD and DSP expert and on a strategic level he enjoys building process-oriented systems within CMC and quality departments along with implementing digital tools for knowledge management and sharing.

Skills include:

  • Process and manufacturing development
  • Process Improvement
  • Process validation strategies
  • Quality by Design expert
  • Process Control Strategy Development and documentation
  • CDMO management
  • ISO-9001 certified auditor
  • Six sigma black belt
  • Generated industry white papers on change management & QbD
Irwin Hirsh
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contactus@greyrigge.com