Senior QC Specialist
Core
Lead technical Quality Control (QC) activities for new vaccine projects, ensuring method validation, equipment qualification, and analytical capacity readiness for transition to routine operations.
Role type
Senior IC QC Specialist (Biopharmaceuticals)
Builds
Validated analytical methods, qualified equipment, and compliant QC testing capabilities for new vaccine products.
Domain
Biopharmaceuticals / Vaccines / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP principles, analytical method validation, method transfer, laboratory investigations, change control management, regulatory compliance, project coordination, equipment qualification, stability testing, data integrity
Preferred skills
MSc in relevant science, environmental monitoring, water system testing, regulatory inspection support, team leadership, continuous improvement
Technologies
LIMS, automated testing systems, robotics, digitalization tools
Responsibilities
Lead method validation, development, verification, and transfer; consult on technical QC matters for regulatory compliance; coordinate validation master plans and training; write/review GMP documents (SOPs, CAPAs, deviations); support transition from project to routine QC mode; perform testing as required for project release.
Seniority
Senior, hands-on IC