Lean Auditor (GxP)

Eurofins Assurance Italia Srl a company of Eurofins group based in Vimodrone (MI) and active with three business units Food Consumer and Healthcare Assurance is looking for a Lead Auditor who will be hired in the Healthcare Assurance department. The Healthcare Assurance department provides the following services to the clients: audits training and consultancy in pharmaceutical medical devices food supplements and cosmetics fields.

We are looking for an experienced Lead Auditor to join our team.

Description of the main activities for the position:

• Performing of audits in EU area as a Lead Auditor according to GMP/ISO standards for the following types of products: Medicinal Products APIs Excipients Medical Devices Packaging Laboratories GxP service providers Cosmetics
• Preparation of an Audit report and related to the audit documents
• CAPA plans evaluation for performed audits
• Collaborate with cross-functional teams to support continuous improvement

Qualifications :

• Possess a Bachelor/Master degree in Scientific fields (Pharmacy Biology Chemistry Biotechnology or related fields).
• Strong knowledge and proven experience in EU and US FDA cGMP and GDP ISO 9001 ISO 15378 ISO 13485
• Have at least 5 years of experience in a pharmaceutical manufacturer in Production QC or QA departments
• Proven experience in auditing activities
• At least 10 audits of suppliers conducted within the last year
• Strong knowledge of auditing processes and applicable regulations
• Analytical mindset attention to detail and ability to work independently
• Be fluent in English and available to travel abroad mostly in Europe
• Be an advanced user of MS Word and MS Excel

Nice to have:

• French language proficiency
• Proven experience in API manufacturing and sterile products manufacturing

Additional Information :

If you are interested in joining a dynamic and challenging environment we look forward to receiving your application.

This position is open to candidates of any gender age or nationality in accordance with applicable laws (903/77 125/91 215/03 and 216/03). Applicants must include authorization for the processing of personal data in compliance with EU Regulation 2016/679 (GDPR).

We reserve the right to close or extend this vacancy depending on the number of applications received. Due to the high volume of applications if you do not receive a response within four weeks of the closing date please consider your application unsuccessful on this occasion.

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Remote Work :

No

Employment Type :

Full-time