Lisa Khuu Email & Phone Number

Edmonds, WA, US

Bothell, Washington, US

Abingdon, Oxfordshire, GB

Shanghai, Shanghai, CN

• Primary QA representative for Equipment Validations, Computer System Validations, SDLC lifecycle documentation, change controls, decommissioning reports, etc. in accordance to 21 CFR Part 11 and GAMP5
• Reviews and approves Change Controls, Decommissioning Reports, etc., in accordance with 21 CFR Part 11 and GAMP5.
• Reviews Testing batch records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable
• Monitor processes for adherence to established procedures/regulatory compliance.
• Provides guidance for quality related issues

US

• Provided testing and technical support in the Microbiology QC Laboratory in variety of functions-validation, in process materials, water, cleaning validation and materials supporting R&D
• Reviewed CMC sections, validation protocols & technical transfer documents per McNeil development and manufacturing procedures based on FDA guides, guidelines, and compliance history.
• Approved GMP documentation
• Updated and optimized procedures to best utilized Lean Six Sigma Practice and compliance

Rahway, New Jersey, US

• Performed all validation and qualifications, for new and existing instrumentation and computer system validation in accordance with Merck and CFR requirements
• Updated and optimized procedures to best utilized Lean Six Sigma Practice and compliance
• Lead rollout of Bioinventory to a department of 200+ employees
• Communicated with purchasing subdivision and exterior vendors to source apparatus and assemblies
• Developing and maintaining SDLC lifecycle documentation, including policies for management of information in environments subject to GxP and QSRs
• Team performance contributed significantly to the expansion of testing capabilities through the addition of seven laboratories

Rahway, New Jersey, US

Brentford, Middlesex, GB