Job Description
Summary
Subject Matter Expert in Aseptic Process Simulation / Media Fill / Sterile Hold validation and system lifecycle, from design requirements analysis to retirement for drug substance and drug product manufacturing.
Job Responsibilities Role & Responsibilities
General:
- Responsible for the validation of Aseptic Process Simulation / Media Fill / Sterile Hold processes and smoke studies 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...