A Few Words About Me

My experience in Quality Management in a Pre-Clinical Company (CRO) and later as a Senior  Global Auditor in a large global pharmaceutical company gives me a broad perspective and expertise in a wide variety of implementation methodologies related to GLP/GCLP Compliance.

I have been working with Quality Assurance arena for more than 18 years.

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Over the years, I have conducted over 500 QA audits in Europe, USA, Canada, Asia, South America, Africa and the Middle East. Audits related to facilities, documents as well as internal audits and for-cause audits.

 

Additional work experience includes:

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  • Build a QA unit including all SOPs and Quality System at an animal facility CRO. Managing the Quality Assurance unit from a non-regulated environment into successful OECD-GLP Accreditation and continuance re-inspections.
     

  • Initiated and lead OECD-GLP highly successful accreditation processes and continuance re-inspections of Global GLP Laboratories.
     

  • Consultancy to manufacturing pharmaceutical company who upgraded from ISO quality level to full GMP accreditation.
     

  • On-going consulting to a QC GLP laboratory upgrading from paper based into computerised systems.
     

  • QA review for regulatory submissions (NDA, IB, IND, Response letters) - GLP and GCLP aspects.