QC Specialist - Project (2-Year Contract)
Core
Provide technical support for Quality Control (QC) activities, validation, and operations for new vaccine projects at GSK Tuas, ensuring compliance and successful transition to routine mode.
Role type
Senior IC QC Specialist (Project)
Builds
New vaccine projects and analytical test methods
Domain
Biopharmaceuticals / Vaccines
Required skills
GMP principles, analytical method validation, laboratory investigations, method transfer, project coordination, regulatory compliance, change control documentation, budget management, safety policies
Preferred skills
MSc in relevant discipline, stability testing, equipment qualification, regulatory inspection support, team leadership
Technologies
Computerized systems, digitalization tools, robotics, automation
Responsibilities
Lead method validation, development, verification, transfer, and new equipment introduction; Provide technical expertise on QC matters to ensure regulatory compliance; Ensure timely project implementation with full compliance; Collaborate with global QC to develop validation master plans and training plans; Write and review GMP documents (SOPs, protocols, CAPAs); Anticipate and execute transition from project to routine QC mode; Manage project budget and resources.
Seniority
Mid-Senior, hands-on IC