Descrizione:
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. Global Technical Operations & Supply Global Technical Operations & Supply (Global Tech Op&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global Tech Op&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners. This is what you will do The Training & Documentation Coordinator is responsible for managing training and documentation across the entire Global Tech Ops & Supply area. Both training and documentation are managed using dedicated systems, which require governance oversight and/or development. A new project has been launched to replace the current document management system; this will require the involvement and coordination of the Training & Documentation Coordinator for its future implementation at the site. You’ll be responsible for:Analysing and gathering the training needs of Parma Plant personnel with respect to GMP topics Organising general GMP courses for Tech Ops staff, either directly or in collaboration with external consultants Issuing the Tech Opstraining programme and preparing the related annual report Participating in the governance team for the training management system, ensuring it remains updated and aligned with regulatory requirements Supporting projects aimed at improving Tech Ops training processes Managing the documentation system in compliance with company guidelines, GMP requirements, regulatory authorities, and certification bodies Participating in the governance team for the current document management system Participating in the project team for the implementation of the new document management system Supervising and supporting the management of the Tech Ops QA archive Providing support during Corporate Quality audits, as well as audits conducted by regulatory authorities and customers Evaluating and authorising requests for access to computerised systems within the Tech Ops area Monitoring training and documentation KPIsYou will need to haveDegree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering) At least 5 years of experience in manufacturing sites within the pharmaceutical and biopharmaceutical sectors, specifically in Quality Assurance, Production, and Process Technology departments. Excellent knowledge of pharmaceutical guidelines (EU and FDA regulations) Specialized expertise in GMP compliance improvement processes Fluent English (both written and spoken)We would prefer for you to haveAbility to establish strategies for managing multiple projects efficiently and effectively Strong teamworking skills, contributing positively and constructively to achieving goals Capacity to analyze technical issues and find shared solutions, evaluating related risks