Freelance Medical Affairs Compliance Auditor

il y a 4 jours

Suresnes, Île-de-France PQE Group Temps plein

Are you ready to join a
world leader
in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries
?
PQE Group
has been at the forefront of these industries
since 1998
, with
40 subsidiaries
and more than
2000 employees in Europe, Asia and the Americas
.

We are looking for a
highly experienced freelance auditor, French speaker, to perform internal audits and self-inspections within pharmaceutical organizations, with a strong focus on Medical Affairs and the management of medical and scientific information in France.
The auditor will evaluate compliance with regulatory requirements, industry standards, and internal procedures, providing independent insights to support quality and continuous improvement.

You will be responsible for

  • Plan and prepare audits based on applicable regulations, internal procedures, and quality standards
  • Conduct audit interviews and inspections (on-site or remote), including opening and closing meetings with staff and management
  • Assess compliance with laws, guidelines, and codes, including:

o French Public Health Code (CSP)

o Good Manufacturing Practices (GMP, GDP, GVP)

o Data protection and privacy regulations (e.g., GDPR)

o Promotional and medical information quality standards

o Internal SOPs and quality policies

  • Draft clear and actionable audit reports with findings, observations, and recommendations
  • Provide input on action plans and follow-up activities
  • Maintain strict confidentiality and integrity throughout the audit process

About you

  • French speaker with excellent written and verbal communication skills
  • Relevant academic or professional qualification certifying ability to conduct quality system audits
  • Extensive experience in the pharmaceutical industry, especially in Medical Affairs, Quality, or Compliance
  • Strong expertise in auditing processes related to medical and scientific information management in France
  • Proven ability to independently plan and execute audits with precision and attention to detail, following the standard audit flow: document collection, agenda preparation, interviews, evidence review, report drafting, and CAPA assessment

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a
challenging, multicultural company that values collaboration and innovation
. PQE Group gives you the
opportunity to work on international projects
, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a
rewarding and exciting career
, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.

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