Investigation Specialist
Core
Investigation Specialist supporting operations in the implementation and delivery of Good Manufacturing Practices (GMP) through technical investigations, process improvements, and documentation management.
Role type
Operations Investigation Specialist (GMP)
Builds
Quality critical metrics improvements, process verification, and standardized operating procedures
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP principles, deviation investigation, CAPA implementation, SOP revision, process improvement tools, technical writing, risk-based decision making
Preferred skills
sterile filtration knowledge, liquid filling components, new facility start-up, lean manufacturing
Technologies
PPI tools, GMP documentation systems
Responsibilities
Complete Deviation investigation and writing Deviation records, Implement CAPAs and change control actions, Revise, improve and simplify SOPs, Maintain focus on positive critical metric position, Highlight training needs to managers, Utilise PPI tools to drive process improvements, Support RAPID Investigation Operations
Seniority
Mid-level, hands-on IC
