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プロフィール詳細

プロジェクトを作成

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Tinus W.に依頼

United Kingdom

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

プロフィール概要

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.

専門分野

サービス

Research
Consulting

Research Fact Checking, Gap Analysis

Consulting Operations Consulting, Scientific and Technical Consulting

職務経験

Senior Quality Specialist

IQVIA (United Kingdom)

5月 2023 - 現在

Quality Specialist

IQVIA

5月 2022 - 4月 2023

Senior Centralized Monitoring Lead

IQVIA

12月 2021 - 4月 2022

Centralized Monitoring Lead

IQVIA

11月 2019 - 11月 2021

Senior Clinic Research Associate

IQVIA

10月 2018 - 10月 2019

Clinical Research Associate II

ICON plc

6月 2018 - 9月 2018

Senior Clinic Research Associate

IQVIA

11月 2017 - 5月 2018

Clinical Research Associate II

IQVIA

4月 2017 - 10月 2017

Clinical Research Associate

IQVIA

7月 2015 - 3月 2017

学歴

BHSc Forensic Science

University of the Witwatersrand (WITS), South Africa

1月 2014 - 12月 2014

BA Psychology

University of Pretoria (TUKS), South Africa

1月 2011 - 1月 2013

認定資格

ICH-GCP E6(R3)

IQVIA

3月 2026 - 12月 2026
ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

9月 2022 - 9月 2024
ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

9月 2020 - 9月 2022
ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

9月 2018 - 9月 2020
ICH-GCP E6(R2) - Expert GCP Exam for Managers and Staff Interacting with Investigational Sites

Barnett Accreditation

9月 2016 - 9月 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