Job Details

This position is responsible for implementing best practices and company policies for non-product software validation and quality assurance directly contributing to quality deliverables for Terumo CVS software and services.  The role will include, but is not limited to working with stakeholders and members of designated project teams to ensure that computerized systems that are used in support of regulated activities and/or business processes, work as intended.

1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
2. Contribute to the applicable business, technical, regulatory, and procedural requirements for software implementations.
3. Contribute to the company’s Quality Standards and Procedures for Computerized Systems, as defined in Terumo CVS’s governing Quality Management System.
4. Responsible for managing and executing the validation of non-product software applications including, but not limited to Enterprise Software, PDM system, CAPA Management system, Reports, Spreadsheets, MES system), Equipment and Automated systems (E&AS).
5. Ensures the audit readiness of the validated systems.
6. Creates validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance releases, and periodic reviews.
7. Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests).
8. Supports risk assessment and system lifecycle processes such as change control and document management.
9. Responsible for systems validation in a regulatory environment, including systems, but not limited to  process automation, enterprise systems, laboratory systems, spreadsheets, management dashboards, or quality systems.
10. Collaborate with Product and project management teams on system-related enhancements as well as issue resolution.
11. Proactively escalate issues and risks appropriately through proper channels.
12. Utilizes the systems and processes in place to attract, develop, engage, train and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
13. Perform other duties as assigned.