Kierownik / Kierowniczka działu kontroli jakości
Core
Leading the Quality Control department for pharmaceutical and medical device production, ensuring compliance with GMP/ISO standards and managing product quality reviews.
Role type
Senior Quality Control Department Manager
Builds
Pharmaceutical and medical device products
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
GMP compliance, ISO standards, quality data analysis, CAPA management, validation studies, stability testing oversight, risk analysis, audit management, team leadership
Preferred skills
Sterile product experience, department management experience
Technologies
GMP, ISO, CAPA, OOS, OOT
Responsibilities
Coordinating QC team tasks and priorities, ensuring timely execution of incoming, in-process, and final product controls, preparing Product Quality Reviews (PQR), analyzing quality data and monitoring KPIs, managing complaints and Out-of-Specification (OOS) investigations, overseeing stability studies and production hygiene, conducting risk analyses, managing validation studies, supervising waste disposal documentation, leading staff training, and participating in internal/external audits.
Seniority
Senior, hands-on IC
