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.
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Responsibilities
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* 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
Key Requirements
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* 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
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* French language proficiency
* Proven experience in API manufacturing and sterile products manufacturing
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. xjrgpwk 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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