Qualified Person

vor 3 Wochen

North RhineWestphalia, Deutschland Discover International Vollzeit

Role: Qualified PersonLocation: North-Rhine Westphalia, GermanyThe Company:A renowned Pharmaceutical company focusing on research in large molecules is currently in search of a Qualified Person to take on batch release responsibilities for one of their leading German sites. This role presents a valuable chance to make a significant impact within the Quality department of a company dedicated to manufacturing life-saving pharmaceutical products.Responsibilities:Monitor the process of product release and ensure that the standards and procedures implemented are up-to-date, accurate, and in compliance with the current Good Manufacturing Practices (GMP) requirements.As a Qualified Person (QP) in accordance with Annexes 16 and 13 of the EU Good Manufacturing Practices (GMP) Guide, the role involves issuing certificates or confirmations for batch release in compliance with local regulations such as the German Medicines Act (AMG) and the German Medicines Manufacturing and Importation Ordinance (AMWHV).Release of imported medicinal products for the manufacture of medicinal products in accordance with EU GMP Guide Annex 21Quality Assurance and Regulatory Affairs departments, as well as other relevant departments, to ensure the effective operation of a pharmaceutical quality management system.Assist in defining and implementing QP processes.Conduct audits of external suppliers and service providers related to QP responsibilities.Take part in manufacturing investigations, including OOS (Out-Of-Specification) investigations and deviations, as a member of the investigation team. Additionally, contribute to the Change Control Management Board.Requirements:Qualified Person by the German authority, as defined in §15 AMGKnowledge on writing SOPsExperience in GMP regulated environmentsFluent in German and English Package:Very flexible hybrid working modelClear progression Path.Friendly and open company cultureFull relocation support

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