QA & C&Q Specialist: System Qualification & Compliance

Pauwels Consulting; Beerse; On-site; EUR 65,000 - 90,000; Full time

Job summary

Pauwels Consulting is seeking a QA Specialist - C&Q to join a leading pharmaceutical organization in Beerse. You will oversee qualification activities and maintain high quality standards across the system lifecycle.

You will review URS, risk assessments and DQ/IQ/OQ/PQ deliverables, support regulatory inspections and internal audits, and collaborate with cross-functional stakeholders to ensure project timelines and quality objectives are met.

Qualifications

• 3+ years of QA or C&Q experience in regulated environments.
• Experience with DQ, IQ, OQ, PQ deliverables.
• Strong knowledge of URS and risk assessment methods.
• Excellent communication and stakeholder-challenging skills.
• Commitment to quality and compliance.

Responsibilities

• Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ).
• Oversee qualification, calibration, maintenance, and lifecycle management of systems.
• Investigate deviations with CAPA implementation.
• Stay current with international regulations and best practices.
• Support regulatory inspections and internal audits as SME for qualification.
• Collaborate with cross-functional teams to meet timelines and quality targets.

Skills

QA

C&Q

Risk assessment

URS

Communication

GxP compliance

Job description

Pauwels Consulting is seeking a QA Specialist - C&Q to join a leading pharmaceutical organization in Beerse. You will oversee qualification activities and maintain high quality standards across the system lifecycle.

You will review URS, risk assessments and DQ/IQ/OQ/PQ deliverables, support regulatory inspections and internal audits, and collaborate with cross-functional stakeholders to ensure project timelines and quality objectives are met.