Oleg Shevaldyshev - Independent GCP QA Consultant

Q: Where is Oleg based?

Oleg is based in Moscow, Russian Federation .

Q: What languages does Oleg speak?

Oleg speaks the following languages: Russian (Native), English (Advanced), Spanish (Elementary) .

Q: How many years of experience does Oleg have?

Oleg has at least 28 years of experience. During this time, Oleg has worked in at least 9 different roles and for 6 different companies . The average length of individual experience is 3 years and 1 month . Note that Oleg may not have shared all experience and actually has more experience.

Q: What is Oleg's latest experience?

Oleg's most recent position is Quality and Training Director at The QARP .

Q: What companies has Oleg worked for in recent years?

In recent years, Oleg has worked for The QARP , Self-employed / Individual Entrepreneur , Dirui Medical , and ICON (formerly PRA Health Sciences) .

Q: Which industries is Oleg most experienced in?

Oleg is most experienced in industries like Pharmaceutical , Healthcare , and Biotechnology .

Q: Which business areas is Oleg most experienced in?

Oleg is most experienced in business areas like Quality Assurance (QA) , Research and Development (R&D) , and Audit . Oleg also has some experience in Project Management , Operations , and Strategy and Planning .

Q: Which industries has Oleg worked in recently?

Oleg has recently worked in industries like Pharmaceutical , Biotechnology , and Healthcare .

Q: Which business areas has Oleg worked in recently?

Oleg has recently worked in business areas like Quality Assurance (QA) , Audit , and Human Resources (HR) .

Recommended expert

Moscow, Russian Federation

Experience

Jun 2024 - Jul 2025

1 year 2 months

Moscow, Russian Federation

Quality and Training Director

The QARP

Oversight of the internal quality system, management of the training center, and maintenance of the quality of audits, consulting, and training services (including the integration of modern training techniques, such as gamification, Artificial Intelligence (AI), and animation)
Development and maintenance of the Quality Management System (QMS)
Conduct of GCP audits and management of corrective and preventive actions (CAPA)
Creation and presentation of training courses

Nov 2023 - Present

2 years 3 months

Moscow, Russian Federation

Independent GCP QA Consultant

Self-employed / Individual Entrepreneur

GCP audits (e.g., investigator sites, vendors, QMS)
QMS management (e.g., development of SOPs and other procedural documents)
Trainings and presentations
Issues / non-compliances (including Serious Breaches) and CAPA management
Risk management
Translation services
Participation in industry events (e.g., RQA Conferences and Special Interest Groups (SIGs))

Jul 2023 - May 2024

11 months

Moscow, Russian Federation

Manager on Scientific Research

Dirui Medical

Managed the setup and execution of scientific research by labs / healthcare institutions, and resulting publications / presentations
Supported the company’s participation in professional exhibitions, conferences and other public events (including facilitation of related scientific symposia)
Managed the re-launch of the company’s web site in Russia
Created the SOPs and related documents
Provided methodological and managerial support of the Medical Devices registration process

Feb 2016 - Apr 2023

7 years 3 months

Moscow, Russian Federation

Director Quality Assurance

ICON (formerly PRA Health Sciences)

Co-led the establishment of the Global Quality Oversight (GQO) processes and team
Initiated and led the Quality Assurance Risk Management Initiative (QA RMI)
Participated in and led various Quality Assurance (QA) activities
Participated in management of various internal audit programs
Participated in revision of procedural documents (Operations and QA SOPs and Planned Process Deviations (PPDs))
Co-led the QA Serious Breach Committee / Quality Investigations / CAPA team
Initiated and led the QA staff on-boarding program
Represented the company in external organizations (MCC, QAF, ACTO, RQA)

Mar 2013 - Sep 2014

1 year 7 months

Moscow, Russian Federation

Head of Representative Offices

INC Research

Feb 2012 - Feb 2016

4 years 1 month

Moscow, Russian Federation

Director, Process Quality Management, Quality Issues

INC Research

Managed multiple Quality Issues (QIs = GxP non-compliances) and related CAPAs
Led the global Quality Issues Management team
Led a project to establish a Serious Breach process globally
Presented several company-wide training sessions for monitors
Participated in electronic Quality Management System (eQMS) upgrade
Participated in SOPs / Guidance Documents creation or review
Co-represented the company at Metrics Champion Consortium (MCC)
Participated in various internal forums to maintain quality and compliance, and process improvement
Created a local Guidance Document to better manage study subjects contacting the company

Mar 2007 - Feb 2012

5 years

Moscow, Russian Federation

Senior Project Manager

INC Research

May 2003 - Feb 2007

3 years 10 months

Moscow, Russian Federation

Senior Clinical Research Associate

INC Research

Sep 1997 - Apr 2003

5 years 8 months

Moscow, Russian Federation

Physician

Clinical Hospital #1 (Volynskaya), President Medical Center

Summary

More than 22 years of overall clinical research experience within global (Top 10) CROs and as a consultant – out of them, more than 13 years in Quality Assurance

GCP Auditing / Quality Assurance (QA) and Quality Management (QM) / Issue and Risk Management, as well as Monitoring and Project Management, experience
Deep knowledge of ICH GCP and related Regulations and Guidance Documents (particularly around Serious Breaches in multiple countries)
Strong Root Cause Analysis (RCA), Corrective Actions / Preventive Actions (CAPA) and Effectiveness Checks skills
Strong management skills
High attention to details and quality of work
Asking the “why?” and “how?” questions
Willing to run an extra mile to make sure the work is done properly
Striving for further development for self and others including QA staff / experts (via trainings – including authoring the “Transition from ICH GCP E6(R2) to E6(R3)” course, presentations, articles, etc.)

Almost 7 years of experience as a physician

Emergency services, including a Stroke Unit: quality = life

Skills

Independent Qa Consultant
22 Years Of Gcp Experience, Including 13 Years In Qa
Non-compliance And Serious Breach Management
Issues / Risk Management
Process Improvement / Qms Management
Gcp Auditing
Publications In Rqa Quasar
Presentations At Various Training Events And Conferences (Including Rqa And Mcc)
Author Of Training Courses (Including “Ich Gcp E6(r3): Transfer From R2”)
Mcc Champion Award For Contributions Around Capa And Risk Management

Languages

Russian

Native

English

Advanced

Spanish

Elementary

Education

Oct 1996 - Jun 1998

Department of Neurology, Postgraduate Medical Center of President Medical Center

Clinical residency, certified neurologist · Neurology · Moscow, Russian Federation

Oct 1990 - Jun 1996

Moscow Medical Academy of I.M.Setchenov

Medical Doctor · Medicine · Moscow, Russian Federation

Certifications & licenses

ISO 19011:2018 – Lead Auditor

ISO 31000:2018

ISO 13485:2016

ISO 9001:2015

ISO 10002:2014

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Oleg based?

Oleg is based in Moscow, Russian Federation.

What languages does Oleg speak?

Oleg speaks the following languages: Russian (Native), English (Advanced), Spanish (Elementary).

How many years of experience does Oleg have?

Oleg has at least 28 years of experience. During this time, Oleg has worked in at least 9 different roles and for 6 different companies. The average length of individual experience is 3 years and 1 month. Note that Oleg may not have shared all experience and actually has more experience.

What roles would Oleg be best suited for?

Based on recent experience, Oleg would be well-suited for roles such as: Quality and Training Director, Independent GCP QA Consultant, Manager on Scientific Research.

What is Oleg's latest experience?

Oleg's most recent position is Quality and Training Director at The QARP.

What companies has Oleg worked for in recent years?

In recent years, Oleg has worked for The QARP, Self-employed / Individual Entrepreneur, Dirui Medical, and ICON (formerly PRA Health Sciences).

Which industries is Oleg most experienced in?

Oleg is most experienced in industries like Pharmaceutical, Healthcare, and Biotechnology.

Which business areas is Oleg most experienced in?

Oleg is most experienced in business areas like Quality Assurance (QA), Research and Development (R&D), and Audit. Oleg also has some experience in Project Management, Operations, and Strategy and Planning.

Which industries has Oleg worked in recently?

Oleg has recently worked in industries like Pharmaceutical, Biotechnology, and Healthcare.

Which business areas has Oleg worked in recently?

Oleg has recently worked in business areas like Quality Assurance (QA), Audit, and Human Resources (HR).

What is Oleg's education?

Oleg attended Department of Neurology, Postgraduate Medical Center of President Medical Center for Neurology.

Does Oleg have any certificates?

Oleg has 5 certificates. Among them, these include: ISO 19011:2018 – Lead Auditor, ISO 31000:2018, and ISO 13485:2016.

What is the availability of Oleg?

Oleg will be available from March 2026.

What is the rate of Oleg?

Oleg's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.