Trợ Lý Quản Lý, Xác Nhận Chất Lượng

Supervises the Quality Validation team by assigning detailed validation work on portions of larger tasks assigned to experienced engineers. Assignments are meant to provide experience and familiarity with validation methods, independent thinking, and company policies.

ESSENTIAL DUTIES

• Manages and guides the Quality Validation group to develop, be effective, follow organizational policies and processes, and support business and corporate targets.

• Acts as the expert and primary contact for Validation matters within the scope of responsibility.

• Reviews and approves relevant validation documents as assigned and within the scope of responsibility.

• Influences the organization on quality goals, prioritization, and resourcing decisions as needed.

• Works as a key internal contributor on validation initiatives that aim to improve product quality, business systems, and compliance; may be the main validation group representative on projects.

• Understands FDA (CFR 820, 211, 210 and 21 CFR 11), ISO (13845 and 14971) and other regulatory requirements and validation guidelines such as GHTF 2004 and FDA Process Validation Guidance 2011, ISPE GAMP5, PDA, ICH etc...

• Ensures compliance with the Quality System and safe working practices.

• Plans, directs, and reviews projects and/or work groups under one's control to achieve the desired outcomes.

• Uses technical skills to assess proposed solutions, adaptations, and changes to projects.