Gofaone Rantsimele

Thorough understanding of Scrum Framework, Kanban Board, Product & Sprint Backlog and Sprint Thorough understanding of Vendor Management Lifecycle and its documentations Interacting with BA and Clients to understand project specific requirements and specifications Responsible for conducting GxP System Assessment and Initial Risk Assessment Documenting Defects in Jira and collaborating with development teams for proper resolution with CAPA

Maintain GxP computerized systems lifecycle, including re-evaluation, Periodic review, Change control, and Deviation management Facilitate cross-functional teams in implementing and maintaining quality practices Ensure timely closure of identified gaps, conducting Root Cause Analysis (RCA), and defining Corrective and Preventive Actions (CAPA) Support client audit for GxP system to demonstrate project compliance Compile Validation deliverables to ensure the product validation compliance

Review service tickets, follow up with teams to conduct investigations and implement CAPA for effectiveness checks Curate and review quality and validation documents to ensure GxP compliance Drafting and revising SOP based on gaps in the process or change in process Conduct periodic revisions of GxP Systems, SOPs, and training modules Utilize QMS tools for Change Control, Non-conformances, and CAPA Conducting internal audit at department level to identify gaps and risk related to process

Phasing Biology