Biologics GMP On-Floor QA & Compliance Specialist

Pauwels Consulting; Eigenbrakel; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a quality assurance professional to support manufacturing of early-stage biologics at a leading biopharmaceutical client in Belgium. This role blends hands-on shop-floor presence with administrative QA tasks to ensure GMP compliance during production.

You will participate in real-time batch monitoring, perform batch record reviews, and drive CAPA and change-control activities, with strong teamwork and communication in a dynamic environment.

Qualifications

• Bachelor or Master degree in a scientific discipline.
• 3+ years of experience in a GMP environment.
• Experience with quality systems including deviations, CAPA, and change control.
• Autonomous, proactive, and able to manage multiple priorities in a dynamic environment.
• Strong teamwork and communication skills.
• Basic knowledge of English.

Responsabilités

• Participate in daily interactions and meetings with production teams on the manufacturing floor.
• Follow manufacturing activities and monitor batches in real time to maintain compliance.
• Perform batch record reviews and manage deviations within the quality system.
• Execute GMP floor checks, compliance tours, and mini-audits when required.
• Collaborate with stakeholders to solve quality issues and manage CAPA and change control processes.
• Handle technical documentation including SOPs, protocols, and reports.

Connaissances

GMP experience

Deviations handling

CAPA management

Change control

Teamwork

Communication skills

English (basic)

Formation

Bachelor or Master in a scientific discipline

Description du poste

Pauwels Consulting is seeking a quality assurance professional to support manufacturing of early-stage biologics at a leading biopharmaceutical client in Belgium. This role blends hands-on shop-floor presence with administrative QA tasks to ensure GMP compliance during production.

You will participate in real-time batch monitoring, perform batch record reviews, and drive CAPA and change-control activities, with strong teamwork and communication in a dynamic environment.