QA / Qualification & Validation Specialist

Il y a 4 jours

Beerse, Antwerpen, Belgique Pauwels Consulting Temps plein 52 000 € - 76 000 € Contrat

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.