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. xlxgzvr
* General Guidance
* Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed.