PQE Group

About the Company

WHO WE ARE

PQE Group is a women-owned, ISO 9001 certified technology solutions and compliance consulting Services Company, offering complete quality solutions for GCP, GLP, GMP, GVP, and GDP areas in the Life Science industry. With over 2,000 employees (40% of whom are women) across 45+ offices globally, we bring together 50+ nationalities and operate in 25+ languages.
We are dedicated to creating value for our customers by leveraging our multidisciplinary teams and expertise, enabling them to achieve and maintain compliance with the latest regulations.

WHAT WE DO

Since 1998, PQE Group has been delivering turnkey quality solutions across the entire product quality lifecycle, focusing on offering cost-effectiveness without compromising quality. Our broad service portfolio and extensive experience have made us the trusted partner for global corporations, as well as small and medium-sized enterprises. To date, we have completed over 25,000 projects worldwide for 1,400+ clients in the pharmaceutical, medical device, SaMD, biotech, veterinary and other life science related sub-industries.

WHY US?

Our proven combination of expertise in project management, wide-ranging services, and exceptional cost-effectiveness makes PQE Group a valuable partner for businesses of all sizes. We help our clients achieve compliance, ensuring that our solutions drive success.

WHERE WE’RE GOING

At PQE Group, we are committed to fostering positive change in the communities and environments where we operate. Through our corporate social responsibility goals, we promote sustainable development, gender equality, environmental protection, and health and safety initiatives. Our partnerships with programs and charity organizations globally reflect our dedication to driving social and environmental impact.

Listed Jobs

Company Name

PQE Group

Job Title

Freelance Medical Affairs Compliance Auditor

Job Description

Job Title: Freelance Medical Affairs Compliance Auditor Role Summary: Conduct independent internal audits of pharmaceutical organizations in France, focusing on Medical Affairs and the management of medical/scientific information. Assess compliance with regulatory, industry, and internal standards; generate actionable findings and support continuous improvement. Expectations: • Deliver timely, high‑quality audit reports and recommendations. • Maintain strict confidentiality and audit integrity. • Work autonomously with minimal supervision, ensuring adherence to audit methodology and timelines. Key Responsibilities: - Plan and prepare audits in line with applicable regulations, internal procedures, and quality standards. - Conduct audit interviews and inspections (on‑site or remote); facilitate opening and closing meetings. - Evaluate compliance with French Public Health Code (CSP), GMP, GDP, GVP, GDPR, promotional/medical information standards, and internal SOPs. - Collect documentation, review evidence, and assess CAPA effectiveness. - Draft clear audit reports with findings, observations, and actionable recommendations. - Provide input on action plans, follow‑up activities, and CAPA implementation. - Safeguard confidentiality and uphold audit integrity throughout the process. Required Skills: - Proficiency in French (written and spoken). - Strong written and verbal communication. - Expert knowledge of regulatory frameworks: French CSP, GMP/GDP/GVP, GDPR, and medical information quality standards. - Proven audit planning and execution expertise, following standard audit flow. - Detail‑oriented, analytical thinking, and ability to work independently. Required Education & Certifications: - Relevant academic or professional qualification certifying competence in quality system audits (e.g., Certified Quality Auditor, ISO 9001 Lead Auditor, or equivalent). - Extensive experience in the pharmaceutical industry, specifically in Medical Affairs, Quality, or Compliance.

Suresnes, France

On site

21-11-2025