Shaker Asad

About Shaker Asad

Summary: Responsible for supporting and assisting all aspects of computerized system validation projects from original concept through final implementation. Work closely with all internal groups creating test validation plans and executing test validation scenarios. Formulate and define Quality Control (QC) validation processes and testing scope for systems through review of project documents, research, and coordination with Project Managers validation project teams. Essential Functions: 1. Serve as validation representative on cross-functional validation teams supporting multiple projects. Interacts with business/system/technical owners, quality assurance, and project management to understand validation project needs and provide support as needed. Develops and maintains high quality documentation including requirements and design documents, risk analysis, installation, operational and performance qualifications protocols, and summary reports. Applies FDA, International Conference on Harmonization (ICH), and other applicable global regulations to the validation of computer systems supporting regulated business processes. Assists in planning, implementing, and documenting user acceptance testing. Performs quality reviews of validation deliverables. Arranges for re-qualification of computer systems as needed. Provides input to Computer System Validation (CSV) procedures review.

Experience

1. Sr Validation Analyst

   ICON plc

   Sep 2019 — Present · US

   Apply FDA, International Conference on Harmonization (ICH), and other applicable global regulations to the validation of computer systems supporting regulated business processes. • Assist in planning, implementing, and documenting user acceptance testing. • Perform quality reviews of validation deliverables. • Arrange for requalification of computer systems as needed. • Provide input to Computer System Validation (CSV) Process. • Serve as validation representative on cross-functional validation teams supporting multiple projects. • Work with business/system/technical owners, quality assurance, and project management to understand validation project needs and provide support as needed. • Develop and maintain high quality documentation including requirements and design documents, risk analysis, installation, operational and performance qualifications protocols, and summary reports.

Education

• N.C. State University

  B.S, Communication; Mass Communication

  1997 — 2005