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With a robust background in Quality Management within a Pre-Clinical Company (CRO) and a Senior Global Auditor in a large multinational pharmaceutical company, my professional journey provides me with a comprehensive perspective and expertise in diverse implementation methodologies related to GLP/GCLP Compliance.


Having conducted audits globally, I embody a unique benchmark, familiar with various approaches of achieving compliance. I bring this wealth of experience to assist you in tailoring procedures according to your specific needs, ensuring alignment with the relevant requirements. My goal is to collaborate with you in navigating between the regulatory requirements, fostering a customized and effective approach to compliance within your organization.

A Few Words About Me

With a rich background spanning more than two decades in the Quality Assurance arena, I have garnered extensive experience and expertise.

Throughout my career, I've conducted over 600 QA audits, across continents, including Europe, the USA, Canada, Asia, South America, Africa, and the Middle East. These audits encompass a wide range, from CROs facilities and document inspections to internal audits and for-cause audits


Additional work experience includes:

  • Building a Quality Assurance unit from the ground up, crafting all Standard Operating Procedures (SOPs) and implementing a comprehensive Quality System at an animal facility CRO. I successfully managed the transformation of the CRO, navigating it from a non-regulated environment to achieving OECD-GLP Accreditation, with continued success in re-inspections.

  • Initiating and leading highly successful OECD-GLP accreditation processes for Global GLP Laboratories.

  • I've provided consultancy to a manufacturing pharmaceutical company, guiding them through a significant upgrade from ISO quality standards to full GMP accreditation.

  • I've contributed to the evolution of a QC laboratory, facilitating their transition from paper-based processes to sophisticated computerized systems. Additionally, I've lent my expertise to a USA-based CRO in the establishment of a new laboratory in Europe.

  • A distinctive aspect of my career involves contracting highly experienced GMP and GCP Auditors on a global scale, emphasizing my commitment to ensuring the highest standards in quality and compliance.

I look forward to leveraging my vast experience and skills to contribute to the success and excellence of your organisation.

Copyright © Orit Galperin. All rights reserved.
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