Infotech Spectrum, Inc. has openings in Santa Clara, CA:
• Develop and implement procedures to include Regulation into current business and product development.
• Review Functional Specifications, Design Specifications, and User Manuals and Training records.
• Work with IT/Infrastructure and Business functions to perform validation.
• Perform 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.
• Supports validation efforts and deliverables for projects requiring validation; validates Enterprise Level applications.
• Create Design Documents, Test Plans and Deployment plans for the Applications throughout the Integration Cycle
• Testing 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 .
• Develop Integration Solutions for cross-platform applications across the enterprise using a wide range of products.
• Translate requirements into logical statements and set up relationship between tables
JOB REQUIRMENT: Required Bachelors or foreign equivalent in CS, CA, CIS, IT, MIS, Engineering ,Pharmacology or any related field. Must be able to travel/relocate to various client sites throughout the U.S.
The technical skills required for this role are:
Electronic Laboratory Notebook (ELN), Laboratory Execution System (LES), Laboratory Information and Management System (LIMS).
Agile development and V-Model.
Testing and Bug Tracking Tools:
HP Quality Center 10, HPALM, Unified Functional Testing (UFT).
FDA Regulations and Guidelines: