Projects

SOP Development for OOS/OOT Investigations

SOP Development Contributor – QC Investigations

Developed a structured SOP framework for handling OOS, OOT, and suspect analytical results defining investigation workflows and documentation requirements. Established procedures for retesting and CAPA implementation ensuring compliance with GMP guidelines while improving traceability and consistency across laboratory investigation processes

Skills Used

• SOP Development
• OOS/OOT Investigations
• GMP Compliance
• CAPA Documentation
• Root Cause Analysis