Freelance Quality Auditor France

Eurofins Healthcare Assurance; Strasbourg; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Eurofins Healthcare Assurance cherche des auditeurs qualité freelance pour réaliser des audits GxP et ISO dans les secteurs pharmaceutique, des dispositifs médicaux et des cosmétiques. Le rôle inclut la gestion de documents, la préparation d'agendas et l'exécution d'audits. Les candidats doivent avoir des connaissances prouvées des normes ISO et un diplôme scientifique pertinent.

Qualifications

• Auditor qualité auto-entrepreneur.
• Minimum de 10 audits internes ou fournisseurs réalisés.
• Fluente en français et flexible pour voyager.

Responsabilités

• Gestion et révision de la documentation pré-audit.
• Exécution des audits sur site ou à distance.
• Rédaction de rapports d'audit et suivi des CAPA.

Connaissances

Connaissance des normes EU GMP, ISO 9001

Connaissance des normes ISO 13485

Connaissance des normes ISO 15378

Connaissance des normes ISO 22716

Connaissance des normes 21 CFR Part 210–211

Connaissance des normes EU GDP

Connaissance des directives IPEC

Formation

Diplôme scientifique (Pharmacie, Chimie, ou Technologies Pharmaceutiques)

Description du poste

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier, and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.

Established in 2019, Eurofins Healthcare Assurance is part of the Eurofins Group, a global leader with over 25 years of expertise in the Testing, Inspection, and Certification (TIC) industry. In 2022, the company expanded its capabilities through the acquisition of Sisthema, a respected Quality Assurance and GxP audit provider founded in 1999

• Operating under the Eurofins Healthcare Assurance brand, the combined team delivers high-quality business assurance services across the pharmaceutical, medical device, cosmetics, and food supplement industries. Our services include audits, certification, training, and consulting—focused on quality management systems, process optimization, risk mitigation, and regulatory compliance .

Position Description :

Due to an increase in subcontracted audits, we are currently seeking freelance Quality Auditors to conduct GxP and ISO audits in the pharmaceutical, medical device, and cosmetics sectors.

Key Responsibilities :

• Management and review of pre-audit documentation.
• Preparation of audit agendas in coordination with clients.
• Collaboration in travel and logistical arrangements.
• On-site or remote execution of audits.
• Drafting of audit reports and audit findings.
• Revising documents based on client feedback.
• Evaluation and follow-up of CAPA (Corrective and Preventive Action) plans.

Qualifications :

• Self-employed Quality Auditor (freelance status).
• Proven knowledge of relevant standards : EU GMP Part I & II, ISO 9001, ISO 13485, ISO 15378, ISO 22716, 21 CFR Part 210–211, EU GDP, IPEC guidelines.
• Scientific degree (preferably in Pharmacy, Chemistry, or Pharmaceutical Technologies).
• Minimum of 10 completed supplier and / or internal audits.
• Fluent in French and flexible to travel within France.

Additional Information

We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development.

We embrace diversity! As an Equal Opportunity Employer, the Eurofins network of companies believes in strength and innovation through diversity. We prohibit discrimination against employees or applications based on gender identity and / or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we count on our dedicated carbon reduction team to help us to achieve this goal!

Find out more on our Careers page : https : / / careers.eurofins.com /

Company description : Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies believes that it is a global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is also one of the market leaders in certain testing and laboratory services for genomics, and in the support of clinical studies, as well as in biopharma contract development and manufacturing. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 37 years, Eurofins has grown from one laboratory in Nantes, France to ca. 63,000 staff across a decentralised and entrepreneurial network of more than 950 laboratories in over 1,000 companies across 60 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2024, Eurofins generated total revenues of EUR 6.95 billion, and has been among the best performing stocks in Europe over the past 20 years.