QA / Qualification & Validation Specialist
Il y a 4 jours
Beerse, Antwerpen, Belgique
Pauwels Consulting
Temps plein
52 000 € - 76 000 € Contrat
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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.