Services

  • Sterile Product Compliance Risk Assessment
  • Training/ Mentoring Shop Floor 
  • Workshops about  Hot Topics Sterile / Aseptic Processing 
  • Audits
  • Troubleshooting "Nonsterilities"
  • Microbiology QA / QC support 
  • Remediation of Quality issues 

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Work Experience

  • QA/QC Microbiology Expertise
  • Start up / upgrade sterile production 
  • Man in Plant / Audits 
  • Sterility Troubleshooting activities
  • Shop Floor Training / Workshops 
  • Aseptic Processing & Terminal Sterilization Expertise
  • Media Fill and Environmental Monitoring 
  • Risk Assessments (HAZOP/ FMEA)
  • Warning Letter Remediation Activities 


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Contractors & Clients

LACHMAN Consultants
Dr. Reddys, KRKA, PQE, SQA
QUANTA Consultancy Services 
Leti / Bracco /McKinsey
Novartis / Glenmark / GE Healthcare, Zydus, Sun ....

About

I am a Microbiologist and have extensive experience in the daily business of Sterile/ Aseptic Production (for Bulk Pharmaceuticals/ Finish Dosage Forms and Biopharmaceuticals) and QA/ QC Microbiology (Sterility Testing/ Microbiology Lab methods)

Tiroler Jungunternehmerpreis 2.Platz 2016 (Click to enlarge, Picture:"Die Fotografen")