Specialist I, Quality Control Systems
Core
Establish and operate a state-of-the-art QC laboratory for new Modulus Facilities in Singapore, ensuring compliance with global quality standards and managing GxP systems.
Role type
Specialist I, Quality Control Systems (QC Systems)
Builds
QC laboratory operations and GxP system infrastructure for vaccine and biological platforms
Domain
Pharmaceutical manufacturing / Quality Control / IT Systems
Required skills
GxP systems management, LIMS administration, 21 CFR Part 11 compliance, data integrity risk assessment, system validation, user access control, SOP authoring, troubleshooting, configuration management
Preferred skills
Regulatory audit experience, project leadership for system rollouts
Technologies
Empower, Omnis, LIMS
Responsibilities
Maintain QC GxP Systems, support Computerized System validation, manage LIMS master data, perform audit trail reviews, conduct data integrity risk assessments, author QC Systems procedures, partner with Digital team on data backup/archival, collaborate on global GxP system upgrades
Seniority
Specialist I, hands-on IC
