Validation Manager, Abbott Healthcare Viet Nam
Core
Lead validation activities and manage the validation team to ensure compliance with regulatory requirements (PIC/S, EU GMP, WHO GMP) for pharmaceutical manufacturing operations.
Role type
Validation Manager
Builds
Validated equipment, facilities, utilities, and computerized systems for pharmaceutical production
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Validation strategy development, cross-functional project management, risk management, budget forecasting, regulatory guideline implementation (PIC/S, EU GMP, WHO GMP), team leadership, change management
Preferred skills
Experience with international partner tools, audit readiness preparation, performance scorecard development
Technologies
MS Office
Responsibilities
Develop and implement validation strategies and project plans, review and approve qualification documents (URS, FRS, DQ, IQ, OQ, PQ) and validation protocols, lead risk management processes, manage the validation team and cross-functional collaboration, forecast and monitor validation budgets, support FAT and PQ activities, update qualification procedures
Seniority
Manager, strategic planning & team leadership
