Auditor Profiles

Andrea Saud Martinez

QA Auditor

Andrea is a Quality Assurance professional with over 30 years’ experience in Pharmaceutical Industry and 16 years’ experience in Quality Systems Development and Management with emphasis on the United States Food and Drug Administration, ICH, global requirements for Good Clinical Practices with emphasis to Latin American countries. Andrea’s multilingual skills allow her to perform GCP site audits in Portuguese, Spanish and English speaking countries. Andrea is very much used to travel covering Latin American countries. Andrea has extensive experience and tracks expressive records of 140 GCP site audit and vendor audits performed to date. Andrea is graduated by Paulista University (Brazil) in Pharmacy and Biochemistry; she holds a Specialty degree in Clinical Pathology and a Master degree in International Businesses.

Steven Bukvic

The CEC, QA Auditor

Steven Bukvic graduated from Coventry University in 1982 with a degree in Applied Biology. After serving in the commercial sector of the UK motor industry for 8 years, Steven joined the Pharmaceutical Industry in 1990. For the next 30 years Steven’s career in the Pharmaceutical / CRO sectors has covered a broad range of disciplines within the field of clinical research. He has also had extensive geographical exposure having worked in the UK, US, Germany, Singapore, China and the CIS.

In his capacity as Regional Clinical Quality Manager with Schering-Plough/MSD, Steven successfully delivered on a variety of GCP audits (both internal company audits as well as site audits across Southeast Asia).

Charles Oviawe

QA Auditor

Charles is a Quality Assurance professional with over 20 year’s experience in Quality Systems Development and Management with emphasis on the United States Food and Drug Administration, ICH and global requirements for Good Clinical Practices, Good Laboratory Practice for Nonclinical Laboratory Studies, Good Pharmacovigilance Practices, Clinical Laboratory Improvement Amendments, current Good Manufacturing Practices and Computer System Validation.

Violeta Ristic

QA Auditor

Violeta is the hard working and dedicated professional with ambition for long-term work in Clinical Research.

Akiko Shibuya

QA Auditor

Akiko has nearly 20 years of  experience  in a series of drug development-related activities, including clinical monitoring, project management, PMDA review management, and GCP inspection management in the clinical development divisions at a pharmaceutical company. Furthermore,  she has experiences in supervising PV and PMS divisions. Based on her various experiences, she proposes the most appropriate audit plan that meets the client’s needs, taking into consideration the Japan’s regulatory situation.

Natalya Makeeva

QA Auditor

More than 20 years ago Natalya started her career in clinical trials as Data management specialist at little local Clinical Research Organization. Continuing her professional journey, Natalya obtained experience of work both in little local and big global pharmaceutical companies and CROs, including Pfizer, Astra Zeneca, Merck Serono, PPD, Nearmedic. In Natalya`s career history there are different positions held within clinical trials area: in the frames of Data Management – since 2003, Clinical Monitoring – since 2006, Project Management – since 2009, Trainings – since 2012, Quality Assurance – since 2015.

Joseph Yammine

QA Auditor

Process & Quality Engineer possessing large expertise in the Quality Management Systems, Auditing, Consultancy, Organizational design and restructuring, compliance, process reengineering, working with a diversified portfolio of clients within Europe, Middle East, Gulf and Africa With my varied experience in several industries, starting by the Healthcare, Logistics, Quality and Education and covering different geographical areas, my professional objective is to assist small to large organizations in designing their systems and structure, so they may be able to transform and upgrade their business.