Antonella Tripaldi

Company Overview:

Infrastructure and Architecture - IT Department of Eli Lilly S.p.a

• Computer systems compliance assessment or validation against regulatory and industry standards:

- GAMP5 software life cycle development model (V model)

- FDA 21 CFR Part 11 on ER, ES

- ALCOA+ principles

• Enhanced overall system performance through meticulous database maintenance and optimization efforts
• Mitigating risks linked to low-quality data ensured enhanced operational integrity through proactive monitoring
• Played key role in successful migration of data to new cloud-based storage system
• Provided expert support, troubleshooting complex technical problems for end-users in a timely manner
• Risk evaluation which includes:

- Regulatory and business requirements associated with computer system

- Type of computer systems (e.g Custom develop or COTS)

• Collaborated with developers and project managers to assess program capabilities, features and testing demands
• Managed quality assurance program, including on-site evaluations, internal audits

• Provided quality assurance during every stage of product development process, from manufacturing to packaging
• Inspected raw materials and finished pharmaceutical products to guarantee quality and safety
• Developed and audited practices, programs and metrics reporting systems to ensure optimal efficiency
• Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders and engineering specifications to ensure contract compliance
• Determined proper corrective actions to bring products in line with requirements
• Collected and modeled data to evaluate trends using [Empower Results]
• Performed routine maintenance and calibration on testing equipment
• Recorded and organized test data for report generation and analysis
• Liaised between quality control and other departments and contractors, providing project updates and consultation