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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.

Auditing across the world makes me a one person benchmark, understanding many ways of doing the right/compliance thing. I will assist you to tailor your procedures according to your needs, under the relevant compliance umbrela.

A Few Words About Me

I have been working in the Quality Assurance arena for more than 20 years.

Over the years, I have conducted over 600 QA audits across Europe, USA, Canada, Asia, South AmericaAfrica and the Middle East. Audits related to CROs facilities, documents as well as internal audits and for-cause audits.


Additional work experience includes:

  • 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.

  • Consulting a QC GLP laboratory upgrading from paper based into computerised systems.

  • Consulting a USA CRO opening a new laboratory in Europe.

  • Contract highly experienced GMP and GCP Auditors, Globally.

Copyright © Orit Galperin. All rights reserved.
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