Summary
Manage Computer System Validation activities and system lifecycle, from design requirement analysis to retirement for drug substance and drug product manufacturing.
Job Responsibilities Role & Responsibilities General: Responsible for the qualification and validation of Computer System 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 resolution of validation variance / issues in a timely and ...