QA Training & Documentation Specialist

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 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 Specialist 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 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

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…