Dev Quality Lab Ops — Data Integrity Partner

UCB; Eigenbrakel; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

UCB seeks a Development Quality Operations Data Integrity Partner based in Braine l’Alleud, Belgium. The role involves ensuring compliance with GMP/GDP regulations and supporting documentation processes in clinical manufacturing.

The ideal candidate has a scientific degree, 5+ years in QA, and fluency in French and English. Essential skills include strong regulatory knowledge, effective stakeholder communication, and analytical problem-solving.

Qualifications

• At least 5 years’ experience in a QA regulated pharmaceutical environment.
• Strong knowledge of regulatory requirements (FDA, EudraLex, PIC/S, ICH).
• Experience in audit and inspection support.

Responsabilités

• Ensure adherence to GMP/GDP regulations and health and safety guidelines.
• Participate in QA forums to manage Data Integrity.
• Coordinate audit preparedness and manage responses to audit observations.

Connaissances

Fluent in French and English communication (oral and written)

Effective communication skills

Analytical and problem-solving capabilities

Formation

Bachelor’s or master’s degree in a relevant scientific discipline

Description du poste

UCB seeks a Development Quality Operations Data Integrity Partner based in Braine l’Alleud, Belgium. The role involves ensuring compliance with GMP/GDP regulations and supporting documentation processes in clinical manufacturing.

The ideal candidate has a scientific degree, 5+ years in QA, and fluency in French and English. Essential skills include strong regulatory knowledge, effective stakeholder communication, and analytical problem-solving.