QC Specialist - Project (2-Year Contract)
Core
Lead QC activities for new vaccine projects, ensuring method validation, equipment qualification, and analytical method transfer while transitioning from project to routine operations.
Role type
Senior QC Specialist (Project)
Builds
Validated analytical methods and qualified equipment for new vaccine manufacturing projects.
Domain
Biopharmaceuticals / Vaccines / Quality Control
Required skills
GMP principles, analytical method validation, laboratory investigations, project management, regulatory compliance, change control documentation, budget management, safety policies.
Preferred skills
MSc in relevant science, stability testing, equipment calibration, regulatory inspection support, team leadership.
Technologies
Computerized systems, digitalization tools, robotics, automation.
Responsibilities
Lead method validation, verification, transfer, and new equipment introduction; consult on technical QC matters for regulatory compliance; develop validation master plans and training plans; write and review GMP documents (SOPs, CAPAs, deviations); anticipate and execute transition to routine QC operations; ensure project spending stays within budget; perform testing as required.
Seniority
Mid-Senior, hands-on IC with project leadership