Services

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.

Dunkles HintergrundbildPortrait von Ing. Thomas Stanzl

My experience

30 Years of professional experience

Protein purification from Fermentation, small and large scale • Process transfer and implementation • Process improvement • Personal Management • Planning and Engineering • Project management skills • Applied cGMP-Knowledge • Generation and execution of Quality Documents; VMP, SOP, batch records etc. • Generation and execution of Validation documents • Risk Analysis • Process Validation • Equipment Validation • Cleaning Validation • Protein purification form Bovine Plasma (large scale) • Plant and Equipment Maintenance •
Audit experience with Regulatory Authorities and Customers (eg. FDA, EU)

Find more information in my CV.