Summary
Manage Temperature Controlled Units qualification and shipping validation activities and system lifecycle, from design requirements analysis to retirement for drug substance and drug product manufacturing.
Job Responsibilities Role & Responsibilities General: Responsible for the qualification of Temperature Controlled Units and shipping validation for the Singapore facilities for Drug Product and Drug Substance Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements
C&Q (Singapore Facilities Start-up) Develop validation SOPs and C&Q deliverables for project start-up and operation readiness Plan, manage and coordinate C&Q activities with internal and external resources/stakeholders Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if required Attend equipment FAT/training as required Track the C&Q deliverables and ensure adherence to schedule from project to operation readiness Lead resolut...