Product Quality Responsible

About the role

Fresenius Kabi is seeking a Product Quality Responsible to ensure the highest standards of quality across its production sites. The role involves supervising documentation, leading validation projects, and driving continuous improvement in line with GMP and ISO standards.

Key responsibilities

• Supervise production documentation, including batch records.
• Lead validation activities for manufacturing processes and equipment.
• Manage CAPA and non‑conformities related to production.
• Coordinate product transfers between sites (e.g., Blonie and Bir Drassen).
• Conduct internal audits and support external audit readiness.
• Develop and review quality procedures, instructions, and records.
• Ensure compliance with corporate, GMP, ISO 9001 and EN ISO 13485 standards.
• Oversee raw material, semi‑finished and finished product testing and release.
• Train laboratory technicians and production personnel on quality control methods.

Required profile

• Strong knowledge of GMP, ISO 9001 and EN ISO 13485 requirements.
• Experience in validation, qualification and CAPA management.
• Proven ability to lead audits and handle non‑conformities.
• Excellent documentation and record‑keeping skills.
• Ability to train and mentor staff in quality processes.

Required skills

• GMP compliance
• ISO 9001
• EN ISO 13485
• CAPA management
• Validation and qualification
• Internal and external audit execution
• Batch documentation control
• Product transfer coordination
• Quality control testing
• Training and mentorship in quality systems