Qa Training & Documentation Specialist

Overview
QA Training & Documentation Specialist is a position within Chiesi Group, on the Global Technical Operations & Supply area, based in Parma, Italy. The role focuses on managing training and documentation across the Global Tech Ops & Supply area, with involvement in a project to replace the current document management system.

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 team working 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
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. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. We offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and relocation support. Chiesi is an equal opportunity employer committed to hiring a diverse workforce.

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.

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