Reginado Berto Nascimento

- Lead End-2-End CSV SDLC documentation for QC laboratory and Manufacturing Computerized Systems such as Validation Plans, FMEA, Requirements Traceability Matrix, Installa-tion/Operational Qualification Test Scripts, Validation Repots, in line with cGMP, GxP, FDA, Swissmedic, EMA, ICH Q9/Q10, GAMP5, 21 CFR Part 11, EU Annex 11 and Data Integrity (ALCOA+) principles. - Support Audit Readiness activities and contributed to maintaining compliance with global regulatory expectations across GMP computerized syst

- Managed and delivered E2E CSV CAPEX/OPEX by developing respective SDLC Validation Documentation, executing Test Protocols, analyzing results and ensuring compliance with cGMP, GxP, FDA, EMA, ICH Q9/Q10, GAMP5, 21 CFR Part 11, EU Annex 11 and Data Integrity (ALCOA+) principles. - Performed CSV Compliance Reviews on GMP released systems. Key Achievements: - Completed 100% E2E RFT CSV activities on Commercial Off-the-Shelf (COTS) systems: Nexgen Plate Readers and Spectrophotometers, Charles River MALDI‑TOF,

- Executed CSV and Process and Equipment Validation, including IQ, OQ and PQ for automated Packaging and Injection Molding Systems. - Developed Validation Protocols, Sampling Plan Strategies and Risk Assessments. - Supported Commissioning and Qualification activities including FAT/SAT and Injection Molding Machines and Tools system implementation. - Supported Internal and External Regulatory Audits and ensured compliance with cGMP, FDA,MDSAP, ISO 13485:2016 and global quality standards. - Conducted DOE, MSA

- Acted as a QC Team Lead as part of the tasks as a QE. - Supported the maintenance of the QMS by Internal and supported External Audits and addressing gaps. - Supported NPI validation activities including VMP, SAT, IQ, OQ and PQ documentation. - Performed E2E validation of Injection Molding Machines and Tools with the support of statistical software tools (Minitab and JMP). - Managed from E2E the of one of a kind complex Vision System designed to reject molding defects from Commissioning Qualification (C

- Played a key role in a team that obtained an internal quality certification - Built-in-Quality, deemed internally as meeting higher standards than current ISO requirements - Responsible for working with all employees to improve processes & eliminate waste - Developed & executed a problem solving training program for the leadership team - Maintained SOPs, 6S checklists, and Standard Work audits - Worked closely with the General Manager to understand and improve the business - Developed visual methods to me

- Preparation and Operation of high speed machinery used in mass car production - Continuous machine monitoring (TPM) including regular checks on the machinery parts & important adjustments wherever necessary - Ensuring high quality manufacture at all times - Initiating Process improvements to improve quality - Maintaining stock of raw materials - Excellent knowledge in transfer and centre machine systems, mainly Nippei Toyama. Quality control – Non-conformances/ CAPA/ Change Control

- In depth learning of the vehicle’s painting process (washing, preparation, PVC, spray primer, spray colours, ovens, polishing etc.) - Troubleshooting of mechanical failures - Repair of components - Support relating to TPM (Total Productive Maintenance) activities

Subjects studied: - Manufacturing Systems Simulations - Heat Transfer and Fluid Dynamics - Computational Heat Transfer and Fluid Mechanics - Product Design and Development Analysis - Advanced Finite Element Analysis - Manufacturing Processes &Tooling Design - Research Practice & Methodology - Entre

Main Subjects Studied: - Electronics - Chemistry - Microprocessors and Micro-controllers - Control Systems - Instrumentation - Servomechanism - Logic Circuits - Applied Mechanics - Manufacturing Processes - Logic Circuits - Industrial Communication Systems - Applied Electricity - Environmental Mana