Software Quality Assurance Computer Systems Validation Specialist - Remote Development & Test
Direct Hire Aug 18, 2023
100% REMOTE - Software Quality Assurance Computer System Validation Specialist opportunity! CSV! Overview: Our client aGlobalmaterials science company is looking for a Software Quality Assurance Computer System Validation Specialist. . In this role, you will be responsible for ensuring the fitness-for-use of the computer systems. The Software Quality Assurance Computer System Validation Specialist will be responsible for working with functions throughout the organization to successfully carry out the computer system validation strategy through a risk-based approach that ensures the quality and integrity of data over the entire system lifecycle. This is a remote position, and you can work from home in most locations within the United States.
Ensure that the quality system elements necessary to achieve and maintain compliance across multiple businesses and varied regulatory requirements, are established and activities related to computer systems/software testing are controlled via these elements
Author, review and/or approve validation plans, protocols, and reports.
Ensure that test cases are documented and executed following the requirements set forth by procedures and external requirements
Work with appropriate teams to establish quality expectations related to software quality assurance and computer system validation
Collaborate with stakeholders in the preparation of software and hardware specification documents and test plans
Author, review and/or approve system change, configuration management, and supporting documentation activities
Participate in external/internal computer system/software audits
Support defect resolution
Support and monitor the qualification of Information Technology Infrastructure Platforms
Minimum 5 years of experience in a computer system validation role in the medical device, pharmaceutical, biotech, or other regulated industry