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Beyond GLP/GCLP, my team of highly skilled Global Auditors and advisors specializes in GCP for Clinical Trials, GMP for Manufacturing Facilities, Pharmacovigilance (PV), and Computerized Systems (IT Compliance), ensuring comprehensive quality oversight across the pharmaceutical industry.

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We manage the agreed scope, choose the right auditor/consultant for the job, coordinate communication and review deliverables, providing consistent oversight and one point of contact.

A Few Words About Me

Founder & Director, Global Pharma QA Ltd
M.Sc. Medical Sciences | Certified Quality Engineer (CQE)

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I bring almost 25 years of Quality Assurance experience, including quality management within a preclinical contract research organisation and global auditing within a multinational pharmaceutical company.

Having conducted more than 650 audits across Europe, North America, South America, Asia, Africa and the Middle East, I bring an international perspective to the assessment of animal facilities, laboratories, research facilities and quality systems.

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My core expertise is in Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP).

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My approach combines technical expertise with clear, respectful communication.

I believe an effective audit should provide a reliable assessment and help people understand the findings, supporting meaningful quality improvements.

 

I ​believe that the greatest value of an audit is not simply identifying compliance gaps, but driving meaningful and sustainable quality improvements.


My approach helps auditees understand and embrace audit observations as opportunities for improvement, fostering trust, engagement, and commitment to implementing effective corrective actions. This provides significant added value to sponsors and clients commissioning the audit by maximising the impact of audit findings and strengthening regulatory compliance and quality systems.


Ultimately, sponsors receive a high-value quality and compliance service that delivers improvements, while auditees strengthen their processes and quality culture, creating a true win-win outcome for all stakeholders.

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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