Quality Systems & Continuous Improvement Specialist
Core
Lead quality systems and continuous improvement initiatives in sterile injectable cartridge manufacturing to ensure GMP compliance and operational excellence.
Role type
Senior IC Quality Systems & Continuous Improvement Specialist
Builds
Robust quality management systems, compliant manufacturing processes, and effective CAPA frameworks for sterile injectable products
Domain
Pharmaceutical manufacturing (sterile injectables) + Quality Systems & Continuous Improvement
Required skills
GMP regulations, risk-based decision making, root cause analysis, CAPA management, process improvement, quality risk assessment, regulatory compliance, data trend analysis, cross-functional collaboration
Preferred skills
Professional Engineer (P.Eng.) license, experience with Health Canada/FDA/EU GMP standards
Technologies
GMP, CAPA, risk assessment tools, manufacturing execution systems
Responsibilities
Lead investigations for deviations and quality events, develop and close CAPAs, conduct quality risk assessments, monitor manufacturing performance data, facilitate cross-functional improvement projects, support audit readiness, provide training on quality systems
Seniority
Senior, hands-on IC