Internal Operations QA Specialist - GMP Biologics

Pauwels Consulting; Eigenbrakel; On-site; EUR 55,000 - 85,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

GMP experience

Deviations handling

CAPA management

Change control

Teamwork

Communication skills

English (basic)

Education

Bachelor or Master in a scientific discipline

Job description

Our client, a leading biopharmaceutical organization, is seeking a professional to support their biological development activities. This role combines operational shop floor presence with administrative quality assurance tasks to ensure compliance during the manufacturing of early-stage biologics. The project requires high adaptability in a dynamic environment where priorities can change frequently.

• 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.

• You have a Bachelor or Master degree in a scientific discipline.
• You bring 3+ years of experience in a GMP environment.
• You possess experience with quality systems including deviations, CAPA, and change control.
• You're autonomous, proactive, and able to manage multiple priorities in a dynamic environment.
• You have strong teamwork and communication skills.
• You have a basic knowledge of English.

Nice to Haves

• Previous experience in biologics production or the pharmaceutical industry.
• Strong knowledge of regulatory requirements.
• Comfort with stakeholder management and interest in continuous improvement.