Biologics Quality Assurance Lead – GMP, CAPA & Deviations

Pauwels Consulting; Eigenbrakel; Sur place; EUR 80 000 - 100 000; Plein temps

Résumé du poste

Pauwels Consulting seeks a Quality Officer to oversee QA for a new biologicals drug substance facility. You will drive continuous improvement, ensure GMP compliance, and lead QA activities across Upstream, Downstream, and Media/Buffer.

The role requires 8 years in a GMP setting, expertise in CAPA, deviation management and change control, and fluency in French and English. You will collaborate with production and quality teams in a dynamic environment.

Qualifications

• Bachelor's or Master's degree in a biotech, chemistry, pharmacy or related field.
• Around 8 years of experience in a GMP environment.
• Demonstrated experience in biologicals drug substance operations from a business or quality perspective.
• Proficient in CAPA, deviation management and change control.
• Strong communication skills and resilience in high-pressure settings.
• Fluency in French and English.

Responsabilités

• Oversee QA activities for Upstream, Downstream, and Media/Buffer operations.
• Review and approve deviations, CAPA, and change controls to maintain compliance.
• Execute the review and approval of batch records for production processes.
• Escalate quality issues to management per QMS protocols.
• Participate in Annual Product Reviews and align quality with production goals.

Connaissances

Quality assurance

CAPA

Deviation management

Change control

Batch records review

QMS

Communication skills

French fluency

English fluency

Formation

Biotech/Chemistry/Pharmacy degree

Description du poste

Pauwels Consulting seeks a Quality Officer to oversee QA for a new biologicals drug substance facility. You will drive continuous improvement, ensure GMP compliance, and lead QA activities across Upstream, Downstream, and Media/Buffer.

The role requires 8 years in a GMP setting, expertise in CAPA, deviation management and change control, and fluency in French and English. You will collaborate with production and quality teams in a dynamic environment.