QA / Qualification & Validation Specialist

Il y a 2 heures

Beerse, Flanders, Belgique Pauwels Consulting Temps plein
pOur 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. /pulliReview and approve qualification deliverables including bURS /b, brisk assessments /b, and bDQ/IQ/OQ/PQ /b protocols and reports to ensure regulatory compliance. /liliEvaluate and approve procedures related to the bqualification /b, bcalibration /b, and bmaintenance /b of systems. /liliManage system-related deviations by ensuring thorough investigations and the implementation of effective bCAPA /b. /liliStay updated on international regulations and industry practices to continuously improve qualification processes. /liliSupport regulatory inspections and internal audits by providing subject matter expertise on qualification topics. /liliCollaborate with cross-functional stakeholders to ensure project timelines and compliance objectives are achieved. /li /ululliYou bring 3+ years of experience in bQA /b or bqualification /b within a regulated environment. /liliYou have knowledge of validation deliverables such as bURS /b, brisk assessments /b, and bDQ/IQ/OQ/PQ /b protocols. /liliYou possess a strong quality and compliance mindset with the ability to challenge stakeholders constructively. /liliYou have excellent communication and interpersonal skills. /li /ulh3Nice to Haves /h3ulliPrior experience in a dedicated bQA /b role. /li /ul