Roche is hiring a Lab Support & ASAT SME to lead equipment qualification, validation, and sample management for a new greenfield facility in Shanghai
Job Summary
Roche is hiring a Lab Support & ASAT SME to lead equipment qualification, validation, and sample management for a new greenfield facility in Shanghai.
The role requires ensuring compliance with global/local procedures, cGMP, and CN/EU Annex-1 standards during both routine operations and project start-up phases.
Candidates must possess strong autonomy to manage laboratory cleanliness, inventory, and data integrity while supporting lean initiatives and digital system deployments.
Matching Summary
Roche is hiring a Lab Support & ASAT SME to lead equipment qualification, validation, and sample management for a new greenfield facility in Shanghai.
Skills & Requirements
Must-have
QC experience in bioanalytical testing
Equipment qualification and validation skills
Knowledge of cGMP and CN/EU Annex-1 regulations
Sample and material management expertise
Fluent English communication skills
Nice-to-have
Greenfield project startup experience
Project management capabilities
MNC Bio-pharma background
Lean initiative implementation
Digital system deployment knowledge
Key Requirements
Bachelor's Degree in Life Sciences or related field
2+ years of QC experience in bioanalytical/bioassay
Experience with aseptic assurance and physical/chemical testing