We are a global service company that specializes in providing dynamic software solutions to a diverse array of business concerns worldwide. Since our inception, we have mastered the unlimited potential of information technology to ensure our global partners have the ability to manage their time and business more efficiently
Job Duties: Develops and implements procedures to include Regulation into current business and product development. Reviews Functional Specifications, Design Specifications, and User Manuals and Training records. Works with IT/Infrastructure and Business functions to perform validation. Performs Risk Assessments on computer systems, modules, and individual programs. Composes and documents validation strategies, Risk Assessments, Requirements Traceability Matrices (RTM’s), Roles & Responsibilities, Installation Qualifications (IQ’s), Operational Qualifications (OQ’s), Validation Summary Reports (VSR’s), and other validation documents as needed. Leads and supports validation efforts and deliverables for projects requiring validation; validates Enterprise Level applications. Creates Design Documents, Test Plans and Deployment plans for the Applications throughout the Integration Cycle. Tests during various phases of test lifecycle throughout the Defect Tracking and Resolution cycles. Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards. Develops Integration Solutions for cross-platform applications across the enterprise using a wide range of products. Translates requirements into logical statements and set up relationship between tables. Assists in Project planning, Risk assessments on computer systems, modules, and individual programs. Reviews SOPs, System Documentation and User Training Manuals to maintain compliance per US FDA.
Job Requirements: Required Masters or foreign equivalent in CS, Information Systems Technologies- Information Assurance, CIS, MIS, Engineering (Any), or any related field. Must be able to travel/relocate to various client sites throughout the U.S.
Location of work: Santa Clara, CA.
To apply please send resumes to HR, Infotech Spectrum, Inc., 2060 Walsh Avenue, Suite 120, Santa Clara, CA 95050. or email resumes…