Lead Auditor (GxP) - Internal or Freelance Full-time Responsibilities Perform audits in the EU area as a Lead Auditor according to GMP/ISO standards for Medicinal Products, APIs, Excipients, Medical Devices, Packaging, Laboratories, GxP service providers, and Cosmetics. Prepare an audit report and related documentation. Evaluate CAPA plans 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. Conducted at least 10 supplier audits within the last year. Strong knowledge of auditing processes and applicable regulations. Analytical mindset, attention to detail, and ability to work independently. Fluency in English and availability to travel abroad, mainly in Europe. Advanced user of MS Word and MS Excel. Nice to have French language proficiency. Proven 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. #J-18808-Ljbffr
Consumer Product Testing
EUROFINS
turbigo, turbigo
Pubblicato 18 giorni fa
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