Spécialiste des systèmes de qualité/Quality Systems Specialist
Core
Develops quality plans, validates manufacturing processes, and ensures compliance with Health Canada and FDA regulations for pharmaceutical/medical device production.
Role type
Quality Systems Specialist (Manufacturing)
Builds
Quality plans, validation protocols, CAPA, and manufacturing procedures
Domain
Pharmaceutical/Medical Device Manufacturing
Required skills
Statistical process control, Validation protocols (IQ/OQ/PQ), Root cause analysis, CAPA management, Regulatory compliance (cGMP), Metrology management, Risk assessment
Preferred skills
Pharmaceutical/Medical device manufacturing experience, Laboratory analytical techniques, Professional quality certifications (CQE/CQA/CQM/RAB)
Technologies
SAP, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Develop and improve quality plans and manufacturing processes; Investigate product complaints and failures; Perform CpK and trend analysis; Draft validation protocols and qualification reports; Manage metrology programs and calibration; Conduct internal and external audits; Provide training on quality systems and calibration.
Seniority
Mid-level, hands-on IC