Key Responsibilities: Compliance & Testing Strategy Prepare and maintain Compliance and Testing strategy documents in alignment with Software Development Life Cycle (SDLC) and Computer System Validation (CSV) Standard Operating Procedures (SOPs). SDLC/QMS Deliverables Ensure that all SDLC and Quality Management System (QMS) deliverables for each project release are completed in accordance with the established strategy documents. User Story Reviews Conduct pre-reviews of user stories and coordinate approvals to facilitate project progression. System Integration Testing (SIT) Pre-review SIT outcomes and coordinate necessary approvals, ensuring that all user stories have been thoroughly tested. User Acceptance Testing (UAT) Prepare UAT test scripts and manage approvals to ensure testing aligns with user requirements. Change Control Management Prepare change control documentation and coordinate associated go-live activities to ensure seamless implementations. Impact Assessments Conduct impact assessments and manage administrative tasks related to deferred bugs, ensuring proper tracking and resolution. Document Reviews Coordinate periodic reviews and updates for living documents such as the Business Impact Assessment (BIA), and Corrective Action (CA) plans. Disaster Recovery (DR) Testing Facilitate and coordinate annual DR testing to validate system recovery processes. Quality Management System Documentation Update and co-update QMS documents as required, including System Administrator SOPs and User Access Procedures. Validation Approach Alignment Collaborate with the Technical Quality (TQ) team to align on validation approaches for edge case scenarios, as necessary. General Guidance Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed.