Qa External Manufacturing & Food Supplements
The Company: Multinational pharmaceutical company is looking for a:
QA External Manufacturing & Food Supplements The Role: Ensure the quality and compliance of purchased pharmaceutical products, including raw materials, finished drug products, food supplements, and medical devicesCollaborate with suppliers, Contract Manufacturing Organizations (CMOs), and internal departments to ensure adherence to GMP, regulations, and company quality standardsEvaluate and qualify suppliers of pharmaceutical products, raw materials, packaging components, and GMP servicesConduct supplier audits, both on-site and remotely, to assess compliance with GMP and quality standardsMaintain and update supplier qualification documentationReview and approve supplier documentation, including specifications, certificates of analysis, production batch records, and change notificationsOversee the inspection and release of incoming purchased productsManage supplier non-conformances, deviations, and complaintsImplement and maintain quality agreements with suppliersSupport internal departments in the investigation and resolution of quality issues related to purchased productsContribute to the maintenance of the company's quality management systemPlan and conduct audits of CMOs and other GMP service suppliers, prepare audit reports, and follow up on corrective actionsCollaborate with Regulatory Affairs to ensure compliance of purchased products with applicable regulations and provide quality input for product registrations and variationsStay up to date with changes in relevant regulations and guidelinesRequirements: Master's degree in Pharmacy, Chemistry, or a related scientific disciplineAt least 5 years of experience in Quality Assurance within the pharmaceutical industry, with a focus on auditingStrong knowledge of GMP regulations, quality systems, and auditing principlesFamiliarity with relevant regulations for pharmaceuticals, food supplements, and medical devicesExcellent communication, interpersonal, and problem-solving skillsProficiency in written and spoken EnglishStrong attention to detail, organizational skills, and ability to work independently and in a teamWork area: Milan
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