Validation Manager, Abbott Healthcare Viet Nam
Core
Lead validation and qualification activities to ensure regulatory compliance (PIC/S, EU GMP) for a pharmaceutical manufacturing site.
Role type
Validation Manager
Builds
Validated equipment, facilities, utilities, and computerized systems for production
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (validation of equipment/facilities)
Required skills
Validation strategy development, cross-functional project management, risk management, budget forecasting, regulatory guideline implementation (PIC/S, EU-GMP, WHO GMP, FDA), document review and approval (URS, DQ, IQ, OQ, PQ, cleaning, analytical method, CSV), team leadership and training, FAT/PV protocol support
Preferred skills
Experience with international partner tools, performance scorecard development, organizational change management
Technologies
MS Office, GMP compliance frameworks
Responsibilities
Lead validation activities to achieve regulatory requirements; Coordinate and strengthen the validation team across functions; Develop and implement validation strategies and project plans; Review and approve qualification/validation documents and risk assessments; Manage annual validation budget; Train the validation team on professional knowledge and audit readiness; Support FAT and PV protocols for new equipment and production lines.
Seniority
Manager, hands-on leadership
