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Profile Details

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Hire Tinus W.

United Kingdom

USD 75 /hr

Senior Clinical Quality Assurance Specialist | GCP Auditing, QMS & Regulatory Compliance Expert

Profile Summary

As a Senior Quality Specialist with extensive experience of more than a decade at a world-leading Clinical Research Organisation (IQVIA) with a background in site monitoring, centralized monitoring and quality management, I specialize in safeguarding clinical trial integrity, driving continuous improvement, and ensuring strict regulatory compliance. Drawing on my qualification as a forensic scientist, I bring a naturally inquisitive, evidence-based approach to clinical quality management and quality assurance. This foundation instilled in me a genuine passion for complex investigations, allowing me to excel at root cause analysis and CAPA management.

I understand the immense pressure life science companies face to maintain inspection readiness and adherence to rigorous international standards. Spaced over 20 hours week I offer remote freelance quality management consulting services to biotechs, pharmaceuticals, and clinical research teams who need top-tier quality assurance without the overhead of a full-time hire.

My core areas of expertise include:
GCP & Clinical Trial Compliance: Ensuring adherence to ICH-GCP, MHRA, EMA, and FDA guidelines across all phases of clinical research.
Auditing & Inspection Readiness: Conducting internal and vendor reviews to identify compliance gaps, and preparing teams for regulatory inspections and customer audits.
CAPA & Issue Management: Leading root cause analysis, developing Corrective and Preventive Actions (CAPA), and tracking them to effective closure.
Quality Management Systems (QMS): Developing and maintaining quality events and controlled records within a QMS.
SOP Reviews: Reviewing, and refining Standard Operating Procedures and controlled documents.

Whether you are a startup or an established sponsor requiring remote and independent QA oversight, mock audits or quality issue investigation, root cause analysis and CAPA management, I provide rigorous, detail-oriented, and actionable quality solutions. Let's connect to discuss how I can support your compliance goals.

Subject Matter Expertise

Services

Research
Consulting

Research Fact Checking, Gap Analysis

Consulting Operations Consulting, Scientific and Technical Consulting

Work Experience

Senior Quality Specialist

IQVIA (United Kingdom)

May 2023 - Present

Quality Specialist

IQVIA

May 2022 - April 2023

Senior Centralized Monitoring Lead

IQVIA

December 2021 - April 2022

Centralized Monitoring Lead

IQVIA

November 2019 - November 2021

Senior Clinic Research Associate

IQVIA

October 2018 - October 2019

Clinical Research Associate II

ICON plc

June 2018 - September 2018

Senior Clinic Research Associate

IQVIA

November 2017 - May 2018

Clinical Research Associate II

IQVIA

April 2017 - October 2017

Clinical Research Associate

IQVIA

July 2015 - March 2017

Education

BHSc Forensic Science

University of the Witwatersrand (WITS), South Africa

January 2014 - December 2014

BA Psychology

University of Pretoria (TUKS), South Africa

January 2011 - January 2013

Certifications

ICH-GCP E6(R3)

IQVIA

March 2026 - December 2026
ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

September 2022 - September 2024
ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

September 2020 - September 2022
ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

September 2018 - September 2020
ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

September 2016 - September 2018

level-one heading

Senior Clinical Quality Assurance Specialist | GCP Auditing, QMS & Regulatory Compliance Expert

Senior Quality Specialist

IQVIA (United Kingdom)

Quality Specialist

IQVIA

Senior Centralized Monitoring Lead

IQVIA

Centralized Monitoring Lead

IQVIA

Senior Clinic Research Associate

IQVIA

Clinical Research Associate II

ICON plc

Senior Clinic Research Associate

IQVIA

Clinical Research Associate II

IQVIA

Clinical Research Associate

IQVIA

BHSc Forensic Science

University of the Witwatersrand (WITS), South Africa

BA Psychology

University of Pretoria (TUKS), South Africa

ICH-GCP E6(R3)

IQVIA

ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation