Senior Specialist Quality Assurance
Core
Senior QA Specialist responsible for shop floor quality management, major quality issue investigation, material release, GMP compliance, and team leadership.
Role type
Senior Specialist Quality Assurance (Pharmaceutical)
Builds
Production quality systems and compliant manufacturing processes
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP knowledge, Quality system management, Quality risk management, Process control methodology, Statistics (Cpk, FMEA), SAP, Team management, Regulatory inspection coordination
Preferred skills
Multi-national enterprise experience, Cross-functional experience, Advanced technology/regulatory trends knowledge
Technologies
SAP, Microsoft applications
Responsibilities
Identify and resolve daily quality risks on the shop floor; Lead investigation of major/critical quality issues; Approve minor deviations and release materials; Draft and approve GMP documents; Manage QA team performance and development; Coordinate regulatory and global audits; Drive cross-functional continuous improvement.
Seniority
Senior, hands-on IC with team management
