Chris Giang Email & Phone Number

Irving, Texas, United States

Provide regulatory and quality compliance guidance with regards to non-product software validation involving GxP/non-GxP systems. Review and Approval of software lifecycle (SLC) Deliverables such as Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Traceability Matrix, Certification Summary Reports etc.Collaborate with the cross functional teams to ensure all business needs are met while maintaining compliance. Review of CAPAs, Change Controls and Defects for GxP/non-GxP systems. Subject matter expert for the non-product software lifecycle (SLC) with experience in participation of internal and external inspections and audits. Strong knowledge of FDA regulations; 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485 and ISO 27001.Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS) and Custom applications

Irving, Tx

- Implement and maintain the effectiveness of the Quality System.- Perform customer complaint investigations regarding the OneLab system, ARCHITECT System software, ARCHITECT instrumentation, hardware, and reagents.- Provide assessment of the technical data and conclusions for the investigations.- Identify deficiencies, as well as, determining root cause of the deficiencies.- Complete investigation reports for ARCHITECT software, hardware, and reagent customer complaints.- Provide on-market product support for various departments within the division. - Provide internal support regarding IT related issues for the Enovia iQ database.- Collaborate with various database teams for timely resolution of issues to minimize impact to daily users.- Participate within software technical review boards regarding issues pertaining to the ARCHITECT System software, as well as the OneLab informatics system.