Based upon 30 years of experience within the Biopharmaceutical/Pharmaceutical industry I’m offering the following services:

OPERATIONS

  • Product/Process Implementation/Improvement
  • Generation/Review of Standard Operation Procedures (SOPs) and Batch Records (BRs)
  • Deviation Handling
  • Staff Training

ENGINEERING

  • Generation of User Requirements for Plants, Utilities and Equipment
  • cGMP driven Problem Solution
  • Support Troubleshooting
  • Ramp-up and Process Optimization

Quality

  • Quality Awareness
  • cGMP Application Support
  • Gap-/Risk-Analysis; Contamination Control Strategy (CCS)
  • Qualification, Verification and Validation Support

If you are interested in my services, please get in touch.