Job Description
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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.
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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
Qualifications
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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
- 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 xlwpduy 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).
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