Validation Analyst

Cignus Solutions, LLC has openings for the position Validation Analyst (4 nos.) with Bachelor's degree or equivalent to work in Quality processes across medical device and regulated industries to manage Complaints and CAPA information systems and work with IT infrastructure Services to gather and draft requirements for qualifying infrastructure. Knowledge of clinical trial process and data management, clinical operations, quality management, and reporting. Prepare High Level and Low level design documents using Microsoft Visio created Sequence diagrams and Activity diagrams. Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards. Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements. Document technical design details and recommend technical design or process changes to improve efficiency, quality, or performance. Coordinate with Process teams for defect resolution throughout the testing cycle for Integration solutions. 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. Work with testers during the Testing cycles in various phases of testing throughout the Defect Tracking and Resolution cycles. Domain knowledge of Pharmacy and healthcare industry preferable.