QA Training & Documentation Specialist (Parma, IT)

04 set - Parma
Biopharma Careers

ph3About us /h3pChiesi 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. /ppAt 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 Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /ppDiversity 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. /ph3Global Technical Operations Supply /h3pGlobal Technical Operations Supply (Global TechOpS) 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 TechOpS 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. /ph3This is what you will do /h3pThe 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.



/ph3You will be responsible for /h3ulliIssue procedures describing the document management system and its requirements /liliArchive documentation and manage the Central Archive of documentation /liliManage the Electronic Documentation Management System (EDMS) to ensure it remains updated and aligned with regulatory requirements /liliProvide user training for the electronic documentation system /liliSupport users in the use of the document management system /liliMonitor documents subject to expiration and ensure that relevant users confirm or revise them as needed /liliVerify documents (Quality Check) /liliManage the distribution of documents to suppliers /liliManage training and documentation, ensuring compliance with regulations /liliParticipate in the governance team for the training management system to keep it updated and aligned with regulatory requirements /liliEvaluate and authorize access requests to computerized systems in the GMD area /liliProvide support during audits by regulatory authorities or clients /liliProvide support during Corporate Quality audits /liliEnter training event data into the training management system and periodically report training data /liliConfigure and modify job roles and corresponding training plans /liliArchive general training documentation /liliSupport users in the use of the training management system /liliOrganize training courses as outlined in the Training Program /liliExtract and process training data from the Learning Management System (LMS) /liliProvide support for training improvement projects in GMD /li /ulh3You will need to have /h3ulliDegree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering) /liliAt 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. /liliExcellent knowledge of pharmaceutical guidelines (EU and FDA regulations) /liliAbility to establish strategies for managing multiple projects efficiently and effectively /liliSpecialized expertise in GMP compliance improvement processes /liliStrong teamworking skills, contributing positively and constructively to achieving goals /liliCapacity to analyze technical issues and find shared solutions, evaluating related risks /liliFluent English (both written and spoken) /li /ulh3Location /h3pParma /ph3Compensation Range /h3pThe minimum salary for this role is € 36.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience,qualificationsand internal equity considerations. /ppIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme. /ph3What we offer /h3pNo 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. /ppWe 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. /ppChiesi 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. /p /p #J-18808-Ljbffr

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