Danrley M. F. Lima

• Played a key role in the development, review, and execution of computerized system validation documents, including Validation Plans, User/Functional Requirements Specifications (URS/FRS), Risk Assessments, Installation/Operation/Performance Qualification protocols and reports, Traceability Matrix, Validation Summary Reports, and Periodic Review reports.
• Collaborated on Computerized Systems Validation projects, contributing expertise to various systems such as Laboratory Systems, Manufacturing Systems (Packaging Lines, Vision/Serialization Systems), and Building Management Systems (BMS).
• Maintained close interaction with clients and external stakeholders, ensuring effective communication and alignment throughout the validation processes.

• Led the development, review, and execution of computerized system validation documents, including Validation Plans, User/Functional Requirements Specifications (URS/FRS), Risk Assessments, Installation/Operation/Performance Qualification protocols and reports, Traceability Matrix, Validation Summary Reports, and Periodic Review reports.
• Successfully validated Track & Trace/Serialization and Warehouse Management System (WMS) to ensure compliance and functionality.

• Conducted technical analysis of patent applications in the HealthCare & Life Sciences fields.
• Prepared responses to technical requirements for patent applications submitted to the INPI (National Institute of Industrial Property).
• Performed translation, review, and analysis of patent documents.

• Conducted internal audits in Manufacturing and Packaging areas to identify potential GMP non-conformities.
• Managed data collection and processing for Products Periodic Quality Review Reports.
• Performed Product Quality Assessments to uphold and enhance quality standards.
• Conducted sampling of intermediate and finished products following NBRs 5426 and 5429 standards.
• Oversaw the receipt, verification, recording, and storage of raw materials and finished products in the Retention Archive, ensuring accurate documentation and timely disposal in accordance with storage guidelines.

Translation, revision, and analysis of patent documents, ensuring accurately technical and high-quality translations.

Undergraduate Research Experience in the field of Organic Chemistry with a focus on the Synthesis of Bioactive Heterocycles, under the guidance of Dr. Thatyana Rocha Alves Vasconcelos. Reserach a project titled "Synthesis of novel heterocycles with potential antitumor activity."

• Analyzed and optimized operational efficiency in Manufacturing and Packaging through Performance Indicator (OEE) analysis, implementing improvement strategies.
• Ensured consistency and quality by monitoring adherence to Standard Operating Procedures (SOPs) during manufacturing processes.
• Reviewed and aligned Manufacturing and Packaging SOPs with industry standards and regulatory requirements.
• Conducted training sessions for operators in Manufacturing and Packaging.
• Managed and maintained the Manufacturing and Packaging Lead Time Spreadsheet, facilitating accurate data for production scheduling and planning across multiple departments within the factory.

Undergraduate Research Experience in the field of Organic Chemistry with a focus on the Synthesis of Bioactive Heterocycles, under the guidance of Dr. Thatyana Rocha Alves Vasconcelos. Reserach project titled "Synthesis of novel heterocycles with potential antitumor activity."