M&S-Sterile Compounding Expert-Beijing
Core
Lead continuous improvement and quality compliance for sterile compounding operations, ensuring GMP adherence and managing deviations, changes, and audits.
Role type
Senior Quality Expert (Sterile Compounding)
Builds
Sterile compounding processes and quality systems
Domain
Pharmaceutical manufacturing / Sterile production
Required skills
GMP knowledge, sterile process expertise, quality system management, deviation investigation, change management, CAPA, gap analysis, HSE management, process optimization
Preferred skills
Compounding process experience, Lean manufacturing, SMS standards, energy management
Technologies
GMP, SMS, Lean, 5S, HSE
Responsibilities
Lead continuous improvement work on sterile compounding PCU; Organize and execute investigations for deviations, complaints, and corrective actions; Coordinate validation execution for processes and equipment; Monitor production environment and hygiene to ensure SOP compliance; Lead self-inspections and global quality audits; Manage procedures for deviations and OOS results; Ensure effectiveness of quality improvement projects; Participate in process optimization and equipment improvement; Fulfill department HSE responsibilities including hazard identification and accident analysis.
Seniority
Senior, hands-on IC
