Quality Assurance Operational Support
Core
Specialist II providing Quality oversight and operational support for GMP manufacturing operations at a new vaccine facility in Singapore, ensuring compliance with global standards and regulatory expectations.
Role type
Specialist II, Quality Operations (GMP Manufacturing Support)
Builds
New generation evolutive multi-product vaccine manufacturing facilities (EVF Project) at Tuas, Singapore
Domain
Pharmaceutical manufacturing (Vaccines/Biologics) and Quality Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP operations, exception management, change controls, deviations/CAPAs, document management, GMP compliance, root cause analysis, regulatory inspection interaction, Quality Risk Management, electronic batch record (MES) review, batch release/disposition processes
Preferred skills
Manufacturing 4.0 mindset, Agile methodology, facility start-up experience, digital manufacturing strategy, SAP system familiarity, Quality plan development
Technologies
Delta V recipe, MES workflows, ERP modules, SAP
Responsibilities
Partner with GMP operations to provide Quality oversight and advice; Review and approve engineering documents, SOPs, and batch records; Support Installation, Operational Qualification (IOQ) and Process Performance Qualification (PPQ) activities; Provide direct QA oversight for on-the-floor operations, raw material release, and deviations; Represent Quality in triaging operational issues and participating in root cause investigations; Champion Quality culture and lead continuous improvement initiatives; Participate in regulatory inspections.
Seniority
Specialist II (Mid-level, hands-on IC)