QA Specialist – Commissioning & Qualification (C&Q)

Randstad Belgium; Beerse; On-site; EUR 60,000 - 90,000; Full time

Job summary

Randstad Belgium is seeking a QA Specialist - C&Q to partner across system lifecycle and qualification projects within a strict GMP environment in Belgium. The role centers on reviewing qualification packages, SOPs, and CAPAs, supporting internal audits and client visits, and collaborating with engineering, validation and operations to meet project deadlines.

Ideal candidates have medior QA experience in Pharma/Biotech and a rigorous compliance mindset, with strong written and verbal

Qualifications

• Medior QA profile with hands-on experience in a strictly regulated environment (Pharma/Biotech).
• Solid background in qualification (C&Q / CQV) deliverables and QA methodologies.
• Rigorous compliance mindset paired with constructive communication skills.
• Ability to manage multiple priorities and maintain strong relationships with stakeholders.

Responsibilities

• Lifecycle & Qualification Oversight: Review and approve critical qualification packages, including URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, and summary reports.
• Compliance & Procedures: Review and approve procedures tied to system qualification, calibration, maintenance, and lifecycle management.
• Quality Investigations: Assess and thoroughly investigate deviations related to system qualification, maintenance, or usage, defining effective CAPAs.
• Audit Readiness: Serve as a subject matter expert for C&Q topics during internal audits, client visits, and regulatory inspections.
• Cross-Functional Collaboration: Challenge constructively and work closely with engineering, validation, and operations teams to meet project deadlines.

Skills

QA in pharma

Regulated environment

CQV knowledge

CAPA handling

Cross-functional collaboration

Job description

Ensuring high-level compliance and robust qualification processes is critical to delivering safe, reliable therapies and healthcare solutions.

We are currently recruiting a QA Specialist - C&Q to act as a key quality partner across system lifecycle and qualification projects.

Your role:

• Lifecycle & Qualification Oversight: Review and approve critical qualification packages, including URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, and summary reports.
• Compliance & Procedures: Review and approve procedures tied to system qualification, calibration, maintenance, and lifecycle management.
• Quality Investigations: Assess and thoroughly investigate deviations related to system qualification, maintenance, or usage, defining effective CAPAs.
• Audit Readiness: Serve as a subject matter expert for C&Q topics during internal audits, client visits, and regulatory inspections.
• Cross-Functional Collaboration: Challenge constructively and work closely with engineering, validation, and operations teams to meet project deadlines.

What we are looking for:

• Medior QA profile with hands-on experience in a strictly regulated environment (Pharma/Biotech).
• Solid background in qualification (C&Q / CQV) deliverables and QA methodologies.
• Rigorous compliance mindset paired with constructive communication skills.
• Ability to manage multiple priorities and maintain strong relationships with stakeholders.

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