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QA Training & Documentation Specialist
Chiesi Group
Source: Headcount Labs · original listing ↗
Job data: Headcount Labs, ODbL 1.0. Job descriptions belong to their employers.
Posted Oct 15
About this role
About us 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 TechOp&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 TechOp&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 Specialist is responsible for managing training and documentation across the entire Global TechOps & 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 Specialist for its future implementation at the site. You will be responsible for • Issue procedures describing the document management system and its requirements • Archive documentation and manage the Central Archive of documentation • Manage the Electronic Documentation Management System (EDMS) to ensure it remains updated and aligned with regulatory requirements • Provide user training for the electronic documentation system • Support users in the use of the document management system • Monitor documents subject to expiration and ensure that relevant users confirm or revise them as needed • Verify documents (Quality Check) • Manage the distribution of documents to suppliers • Manage training and documentation, ensuring compliance with regulations • Participate in the governance team for the training management system to keep it updated and aligned with regulatory requirements • Evaluate and authorize access requests to computerized systems in the GMD area • Provide support during audits by regulatory authorities or clients • Provide support during Corporate Quality audits • Enter training event data into the training management system and periodically report training data • Configure and modify job roles and corresponding training plans • Archive general training documentation • Support users in the use of the training management system • Organize training courses as outlined in the Training Program • Extract and process training data from the Learning Management System (LMS) • Provide support for training improvement projects in GMD You will need to have • Degree 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 with a solid track record in the above-mentioned activities. • Excellent knowledge of pharmaceutical guidelines (EU and FDA regulations) • Ability to establish strategies for managing multiple projects efficiently and effectively • Specialized expertise in GMP compliance improvement processes • Strong teamworking skills, contributing positively and constructively to achieving goals • Capacity to analyze technical issues and find shared solutions, evaluating related risks • Fluent English (both written and spoken) Location Parma Compensation Range The minimum salary for this role is € 36.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.