Quality Systems Specialist - Documentation

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Job Description

About the role:

The Quality Compliance and Systems II role focuses on ensuring the quality of processes and product outputs. This position is responsible for defining activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and reporting on deviations and defects. This role supports Takeda's mission by maintaining high-quality standards and ensuring compliance with regulatory requirements.

How you will contribute:

• Define and specify activities, processes, and standards to fulfill quality requirements
• Audit and monitor the quality of processes or outputs against defined standards
• Conduct product integrity testing to ensure compliance with quality requirements
• Report on process deviations and defects
• Apply basic analytical methods and operational processes following standard operating procedures
• Communicate with immediate team, focusing on clear and simple information exchange

What you bring to Takeda:

• Proficiency in using electronic document management systems (e.g., Veeva Vault).
• Proficiency in French and English (minimum B2 level or equivalent).
• Proficiency in Microsoft Office tools, including Word, Excel, Power Point and SharePoint.
• Minimum 2 years of experience in the (bio)pharmaceutical industry, ideally in a multinational company.
• Familiarity with GMP and regulatory guidelines (e.g., 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.

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