My Client has an urgent need for a QA Validation Engineer. They are responsible for the test planning, execution, validation and the quality assurance of our enterprise validated laboratory information management systems (LIMS) including other business application systems.
Plan, design, develop and execute test plans and test cases ensuring thorough coverage and traceability to business and functional requirements.
Writes and reviews validation documentation including validation plans, risk assessments, test scripts, data migration plans/reports, traceability matrix and summary reports.
Review business requirements, functional requirements and technical specifications for software development projects.
Convert requirements and specifications into written test plans, test cases and test scripts.
Analyze requirements, develop test plans and test cases translating from requirements and preparing test data.
Work closely with development and project management teams during application design and development sessions.
Focus on quality issues across multiple projects, major changes and releases.
Provides guidance with functional/ end user requirements, compliance and system specifications, and ensures that proper documentation is maintained.
Identify and analyze software quality assurance risks and any mitigations.
Perform periodic reviews and remediation activities on validated systems with Regulatory team.
Assist with audits such as CAP, ISO, FDA etc. to provide necessary procedures and documentation.
5 years’ relevant experience as working as a Software QA Validation Engineer in a highly fast-pace, scalable and reliable IT environment.
Experience with automated systems for the following activities/functions preferred
Laboratory Information Management System/Laboratory System (LIMS/LIS)