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
