Founded in 2005 by a group of Software Quality Assurance Engineers, SQA Solution is your global partner in Software Quality Assurance and Release/Configuration Management. Provide leadership and expertise in the interpretation, development, and implementation of global policies to ensure compliance of digital systems with cGMP, 21 CFR Part 11, Annex 11, and GAMP requirements.Collaborate with corporate functions to ensure continuous and verifiable compliance throughout the entire GMP digital environment and lifecycle.Support the overall readiness of the CSV program and computer-related systems for audits and regulatory inspections.Review and assess GXP-related computer system change controls, investigations, CAPA, periodic reviews, and system access in alignment with procedures.Approve validation plans, protocols, reports, and other verification/validation documentation for GXP computer systems.Assess systems for data integrity and compliance with regulatory expectations, including third-party IT service suppliers and applications.Participate in and support the external audit program for vendors related to GXP computerized systems.Provide QA guidance in developing and revising GXP computer system procedures.Work with system owners and administrators to address priorities for GXP computer system configuration, security, profiles, and migration plans for compliant implementation.Perform quality support duties, including maintaining and executing quality management system processes in Veeva.Provide ongoing quality support, advice, and guidance to GXP-related system owners and administrators.Effectively manage priorities, multiple projects, and communication with all levels of personnel. * Automation and Performance * Black Box * Compatibility Testing * ERP Integration with Legacy Systems * iPhone Application Testing * FDA Computer System Validation * Data Warehouse Testing * SQA Consulting Services * Test Documentation

SAP SQA PM