QA / Qualification & Validation Specialist

Pauwels Consulting; Beerse; On-site; EUR 52,000 - 76,000; Full time

Job summary

Pauwels Consulting is seeking a qualified QA professional to oversee compliance across the system lifecycle and manage qualification activities in a regulated environment. You will review URS, risk assessments, and DQ/IQ/OQ/PQ protocols while ensuring CAPA-driven improvements.

The role emphasizes collaboration with cross-functional teams to meet project timelines and regulatory expectations. Ideal candidates have 3+ years in QA/qualification, strong knowledge of validation deliverables, and

Qualifications

• 3+ years of experience in QA or qualification within a regulated environment.
• Knowledge of validation deliverables such as URS, risk assessments, and DQ/IQ/OQ/PQ protocols.
• Strong quality and compliance mindset with the ability to challenge stakeholders constructively.
• Excellent communication and interpersonal skills.

Responsibilities

• Review and approve qualification deliverables including URS, risk assessments, and DQ/IQ/OQ/PQ protocols to ensure regulatory compliance.
• Evaluate and approve procedures related to qualification, calibration, and maintenance of systems.
• Manage system-related deviations by ensuring investigations and effective CAPA implementations.
• Stay updated on international regulations and industry practices to improve qualification processes.
• Support regulatory inspections and internal audits by providing SME on qualification topics.
• Collaborate with cross-functional stakeholders to meet timelines and compliance objectives.

Skills

QA experience

Regulatory compliance

Documentation

Cross-functional collaboration

CAPA

Job description

Our client, a prominent player in the healthcare industry, is seeking a professional to join their quality team. The role focuses on overseeing compliance throughout the system lifecycle and managing qualification activities within a regulated environment.

• Review and approve qualification deliverables including URS, risk assessments, and DQ/IQ/OQ/PQ protocols and reports to ensure regulatory compliance.
• Evaluate and approve procedures related to the qualification, calibration, and maintenance of systems.
• Manage system-related deviations by ensuring thorough investigations and the implementation of effective CAPA.
• Stay updated on international regulations and industry practices to continuously improve qualification processes.
• Support regulatory inspections and internal audits by providing subject matter expertise on qualification topics.
• Collaborate with cross-functional stakeholders to ensure project timelines and compliance objectives are achieved.

• You bring 3+ years of experience in QA or qualification within a regulated environment.
• You have knowledge of validation deliverables such as URS, risk assessments, and DQ/IQ/OQ/PQ protocols.
• You possess a strong quality and compliance mindset with the ability to challenge stakeholders constructively.
• You have excellent communication and interpersonal skills.

Nice to Haves

• Prior experience in a dedicated QA role.