DAVI DE MATOS ALVES

Performed QA/QC inspection and follow-up for installation, fabrication, and commissioning of clean and industrial utilities, ensuring compliance with engineering specifications and GEP concepts. Managed non-conformances, deviations, and CAPAs, and utilized Microsoft 365, e-Clic, Python, PowerShell, Google Forms, and Apps Script for process automation.

Supervised 3rd-shift maintenance and managed contracts, procurement (SAP MM), and utilities operations (Water, HVAC, Boilers) at the Novamed unit. Utilized SE Suite for document management, actions, deviations, and change controls assessments to ensure GMP compliance.

Elaborated and executed complete validation packages including Risk Assessments, DQ/IQ/OQ/PQ protocols, Traceability Matrices, and Qualification Reports for various systems. Served as primary point of contact for vendors regarding validation subjects and participated in retirement planning.

Elaborated SOPs for laboratory equipment and executed complete validation packages for computerized systems (vision system and labeling) for syringe and vial packing machines, following FDA regulations 21 CFR Part 11 and 21 CFR Part 820. Served as primary point of contact for vendors on validation subjects.

Managed cleaning and process validation activities.

Managed validation, calibration, and qualification activities, including contracts, personnel development, Validation Master Plan, CSV, CQV, and validation SOPs. Elaborated and executed FAT, SAT, RA, DQ, IQ, OQ, PQ, and QR for a complete oral liquid line, and served as primary point of contact for vendors.

Managed validation, calibration, and qualification activities, including contracts, personnel development, Validation Master Plan, CSV, CQV, and validation SOPs. Demonstrated expertise in cleaning validation and successfully presented during GMP inspections for ANVISA.

Managed validation, calibration, and qualification activities, including contracts, personnel development, Validation Master Plan, CSV, CQV, and validation SOPs. Utilized Microsoft Project and SE Suite for document and change control management.

Managed qualification activities, including contracts, personnel development, and validation SOPs. Utilized SE Suite for document and change control management.

Led GAP assessments for validation, CSV, and CQV processes, and supported routine validations and a major greenfield project for a new production line. Executed equipment qualifications and CSV for critical systems, and managed CIP/SIP and process validations.

Performed analysis of raw materials, in-process control, and finished products using various classical and instrumental analytical techniques, including UPLC, GC, ICP, and particle counters.

Performed chemical analysis in industrial water and provided field technical support for water treatment.

Developed agrochemical formulations and analysis methods (HPLC & GC) and provided technical support for manufacturing new products.

Performed chemical analysis using HPLC & GC methods and managed Statistical Process Control.

MBA in Project Management, in progress with expected completion in 2027.

Bachelor of Science in Chemical Engineering, completed in 2015.