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 650 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
Combining technical Quality Assurance expertise with exceptional interpersonal and communication skills, enabling me to conduct audits in a constructive and collaborative manner. 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 measurable improvements, while auditees strengthen their processes and quality culture, creating a true win-win outcome for all stakeholders.
I specialize in preparing companies for GLP/GCLP accreditations and compliance, beginning with a comprehensive Gap Analysis (Mock Inspection). My consultation services focus on building and optimizing Quality Systems and SOPs, leading to successful GLP/GCLP Accreditation & Compliance (See GCLP Certification page).
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.
I look forward to leveraging my vast experience and skills to contribute to the success and excellence of your organisation.