About this role
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, CosmeticsPreparation of an Audit report and related to the audit documentsCAPA plans evaluation for performed auditsCollaborate with cross-functional teams to support continuous improvement 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 13485Have at least 5 years of experience in a pharmaceutical manufacturer in Production, QC or QA departmentsProven experience in auditing activitiesAt least 10 audits of suppliers conducted within the last yearStrong knowledge of auditing processes and applicable regulationsAnalytical mindset, attention to detail, and ability to work independentlyBe fluent in English and available to travel abroad, mostly in EuropeBe an advanced user of MS Word and MS ExcelNice to have:
French language proficiencyProven experience in API manufacturing and sterile products manufacturing 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.
Ready to make a difference? Learn more about Eurofins: www.eurofins.com, www.eurofins.it