Quality Documentation Specialist (m/w/d)

Tasks :

• The primary responsibility of this role within the Quality organization is to perform activities related to the documentation process and system, including archiving activities, provide user support for documentation related tasks, contribute to continuous improvement efforts and site initiatives, and ensure adherence to internal procedures and regulatory requirements

• Act as System/Process Owner or Administrator for the assigned process(es)/system(s).

• M aintain the Documentation Quality System, including proper archiving activities.

• Assist end users with processes or systems in area of responsibility and with resolution of issues.

• Train users and manage associated training toolkits.

• Process users accounts requests for the system(s) in area of responsibility.

• Create, update, approve and archive documents in area of responsibility.

• Participate in the continuous update of the team’s SharePoint

• Collaborate with our Business partners on site, other Takeda sites or Global to implement changes and improvements of systems.

• Proactively assist our business partners in expressing their needs to provide an adapted solution.

• Acts as Quality Representative in both routine and facility projects to support the quality system deployment and application to meet the current Regulatory Requirements

Qualification:

• Degree in pharmaceutical sciences, life sciences, or a related scientific discipline.

• Minimum 2 years of experience in the (bio)pharmaceutical industry, ideally in a multinational company.

• Knowledge with GMP and regulatory guidelines (e.g., US-FDA, EMA, ICH).

• Good understanding of Good Data and Documentation Practices (GDDP) and Data Integrity principles.

• Knowledge of document version control, document workflows, and archiving.

• Awareness of audit and inspection readiness requirements.

• Proficiency in using electronic document management systems (Veeva Vault)

• Proficiency in French and English (minimum B2 level or equivalent)

• Proficiency in Microsoft Office tools, including Word, Excel, Power Point and SharePoint

• Capability to troubleshoot quality-related issues and propose effective solutions

• Ability to identify gaps or inconsistencies in quality systems or documentation compared to internal procedures and external regulations

• Works with all other site functions and corresponding Global Quality Documentation representatives

• Act as a back up of other Quality Systems team member as required

Requirements:

Start : 01.10.2025