Liwen Luan

Background

About Liwen Luan

Over 20 years of diverse and progressive experience including quality system development and maintenance, method/technology validation and transfers in the pharmaceutical & biotech industry• A thorough understanding of Quality/Compliance as it relates to a cGMP, GLP regulated environment and the ability to navigate in a networked system• Deep knowledge of Health Canada, FDA, ICH regulatory requirements• Extensive experience in pharmaceutical & biologic importing/distributing environments and in managing of 3PL• Sound experience with testing and reviewing using in-house, USP, BP, and EP methodologies in a laboratory environment• Extensive knowledge of Batch release and Agency Lot release documentation preparation and submission• Competencies in collaboration, responsiveness, commitment and integrity• Adept managing multiple projects in a fast-paced environment and ensuring those projects are completed to meet strict deadlines• Dedicated team player that consistently exceeds expectation on all quality services and leadership requirements• Excellent organizational, communication, problem-solving, analytical and report writing skills• A Sanofi Certified auditor• Proficient in SAP, LIMS, Veeva Vault (e.g, Regulatory documentation; Quality documentation), Waters Empower and MS Office: Word, Excel, PowerPoint