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pstronguThe Company: /u /strong /ppbr/ppMultinational pharmaceutical company is looking for a: /ppbr/ppbr/ppstrongQA External Manufacturing - Sterile Food Supplements /strong /ppbr/ppstronguThe Role: /u /strong /ppbr/pulliEnsure the quality and compliance of purchased pharmaceutical products, including raw materials, finished drug products, food supplements, and medical devices /liliCollaborate with suppliers, Contract Manufacturing Organizations (CMOs), and internal departments to ensure adherence to GMP, regulations, and company quality standards /liliEvaluate and qualify suppliers of pharmaceutical products, raw materials, packaging components, and GMP services /liliConduct supplier audits, both on-site and remotely, to assess compliance with GMP and quality standards /liliMaintain and update supplier qualification documentation /liliReview and approve supplier documentation, including specifications, certificates of analysis, production batch records, and change notifications /liliOversee the inspection and release of incoming purchased products /liliManage supplier non-conformances, deviations, and complaints /liliImplement and maintain quality agreements with suppliers /liliSupport internal departments in the investigation and resolution of quality issues related to purchased products /liliContribute to the maintenance of the company’s quality management system /liliPlan and conduct audits of CMOs and other GMP service suppliers, prepare audit reports, and follow up on corrective actions /liliCollaborate with Regulatory Affairs to ensure compliance of purchased products with applicable regulations and provide quality input for product registrations and variations /liliStay up to date with changes in relevant regulations and guidelines /li /ulpbr/ppstronguRequirements: /u /strong /ppbr/pulliMaster’s degree in Pharmacy, Chemistry, or a related scientific discipline /liliAt least 5 years of experience in Quality Assurance within the pharmaceutical industry, with a focus on auditing /liliHolds the Qualified Person (QP) qualification, or meets the eligibility criteria for its attainment /lilistrongProven experience in sterile manufacturing environments /strong and thorough understanding of associated GMP requirements /lilistrongSound knowledge of food supplements regulations and production processes /strong /liliStrong knowledge of GMP regulations, quality systems, and auditing principles /liliFamiliarity with relevant regulations for pharmaceuticals, food supplements, and medical devices /liliExcellent communication, interpersonal, and problem-solving skills /liliProficiency in written and spoken English /liliStrong attention to detail, organizational skills, and ability to work independently and in a team /li /ulpbr/ppstronguWork area: /u /strong /ppMilan /p