Lead Auditor (GxP)

Responsibilities

• Perform audits in the EU area as a Lead Auditor according to GMP/ISO standards
• Audit products including Medicinal Products, APIs, Excipients, Medical Devices, Packaging, Laboratories, GxP service providers, and Cosmetics
• Prepare audit reports and related documentation
• Evaluate CAPA plans for performed audits
• Collaborate with cross-functional teams to support continuous improvement

Requirements

• Bachelor or Master degree in Pharmacy, Biology, Chemistry, Biotechnology, or related scientific fields
• Strong knowledge of EU and US FDA cGMP, GDP, ISO 9001, ISO 15378, and ISO 13485
• At least 5 years of experience in pharmaceutical manufacturing (Production, QC, or QA)
• Proven experience in auditing activities
• Conducted at least 10 supplier audits within the last year
• Fluency in English
• Ability to travel abroad, primarily within Europe
• Proficiency in MS Word and MS Excel

Preferred Qualifications

• French language proficiency
• Experience in API manufacturing
• Experience in sterile products manufacturing

About the Company

Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries to ensure products are safe, authentic, and accurately labeled.