Rita Carmelo

• Lead the Validation team (2 team members), overseeing planning, execution, and documentation of validation activities for pharmaceutical and life science clients.
• Provide QA support across GxP-regulated projects, ensuring compliance in validation, documentation control, and internal quality systems.
• Develop and maintain comprehensive documentation, including SOPs, validation manuals, QMS components, and all required Health & Safety (H&S) documentation in accordance with regulatory standards.
• Implement validation systems and lead data migration initiatives, aligning technical processes with compliance requirements.
• Lead validation of the DAQUMA AI platform.
• Coordinate cross-functional internal projects, contributing to marketing efforts, event planning, and process optimization.
• Actively pursuing training in GMP auditing and regulatory compliance to further strengthen QA expertise.
• Developed training programs to enhance employees'' understanding of quality standards and expectations.

- Vendor analysis and selection: Application area report, interview script and interview finding, RfI and RfP
- Project Management: Project info pack and participant, decision and action lists
- eLearning: Pharma business and IT project execution, Business case development, process analysis, organizational change management, vendor selection, IT system validation, application architecture, CFR 21 part 11, pharma and enterprise architecture