Product Features
Blog
Contact Us
Sign In
Signant Health
,
London, Greater London
Quality Management Specialist
Overview
The QM Specialist is responsible for understanding software validation in a government regulated environment with special attention to the Software Development Lifecycle (SDLC) validation processes which meet regulatory requirements. The QM Specialist ensures that all study work is conducted to Signant Health’s procedures and processes and supports the Validation Methodologies. The QM Specialist is also responsible for providing mentorship/leadership. The position requires a high level of integrity as this person is working on a client’s project and preparing documents that may be submitted to regulatory agencies (FDA, EMEA etc.) as needed, and actions impact the quality and reliability of the client's’ project. Key Accountabilities/Decision Making & Influence: Work with internal staff in implementation of improved capabilities in the areas of documentation and validation. Assist in performing analysis of current validation situations, review internal controls. The QM Specialist will be familiar with Software Validation regulatory expectations. Attention to detail is expected to ensure high quality documentation. Assist with coordinating the implementation or scheduling of validation with affected departments and personnel. Collaborates with other departments to ensure validation activities are executed in a compliant fashion. Interface with Client Services, Technical Delivery, QA, and Support Staff to ensure compliance with the SDLC/PLC. Review documentation for accuracy and completeness, tracking and driving completion of Validation milestones per the project schedule. Assess current validation processes to ensure effectiveness. Propose validation improvement suggestions. Serve as trainer for Validation training. Compose and document validation strategies; Validation Plans, Validation Summary Reports, and other validation documents as needed. Review documentation for accuracy and completeness, tracking and driving completion of Validation milestones per the project schedule. Creation of detailed Validation execution schedules. Providing quality oversight, cross-checks and approvals. Interface with Project controls. Attend project meetings. Knowledge, Skills & Attributes Bachelor’s degree or commensurate experience. At least 2-4 years industry experience required. Supporting multiple projects/processes in a fast-paced work environment.