QA Specialist - C&Q

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

Our client, a leading pharmaceutical organization, is seeking a QA Specialist - C&Q to join their team. This role focuses on ensuring compliance across the system lifecycle by overseeing qualification activities and maintaining high quality standards.

• Review and approve qualification deliverables such as URS, risk assessments, and DQ/IQ/OQ/PQ protocols and reports.
• Oversee procedures related to the qualification, calibration, maintenance, and lifecycle management of systems.
• Assess and investigate deviations related to system qualification and use, ensuring effective CAPA implementation.
• Stay updated on international regulations and industry practices to continuously improve qualification processes.
• Support regulatory inspections and internal audits as a subject matter expert for qualification-related topics.
• Collaborate with cross-functional stakeholders to ensure project timelines and quality objectives are met.

• You have 3+ years of experience in QA or C&Q within a regulated environment.
• You bring expertise in qualification deliverables including DQ, IQ, OQ, and PQ.
• You possess a strong knowledge of URS and risk assessment methodologies.
• You're an excellent communicator with the ability to challenge stakeholders constructively.
• You possess a strong quality and compliance mindset.

Nice to Haves

• Experience with CAPA and deviation management systems.
• Knowledge of international industry practices for system qualification.