Adson Ruan Gonçalves Email & Phone Number

Brazil

Hortolândia, São Paulo, Brasil

Working at Rio Biofarma Brasil (RBBL), part of the NC Group, on the activities described below, with a focus on meeting the regulatory requirements of the FDA, ANVISA and INFARMED agencies:- Process Validation and Holding Time (Phase 2)- Cleaning Validation (Phase 2 and Phase 3)- Qualification for Visual Inspection of Equipments- Sterilizing Filtration Validation- Aseptic Process Simulation (Media Fill)- Continued Process Verification (Phase 3)- Contamination Control Strategy (CCS)Routine activities include defining validation strategies, managing schedules, drafting, reviewing and executing risk analyses, protocols and reports for validation studies, as well as executing protocols for validation studies.

Anápolis, Goiás, Brasil

Responsible for managing and executing the activities of the Validation studies described below, with a focus on meeting the regulatory expectations of the DIGEMID, INVIMA, ANVISA and EMA agencies:- Process Validation and Holding Time (Phase 2)- Cleaning Validation (Phase 2 and 3)- Continued Process Verification (Phase 3)- Filtration Validation (Sterilizing Membrane)- Aseptic Processing Simulation (Media Fill)- Irradiation Sterilization ValidationDuring my time at the company, I led and actively participated in the following projects, as well as investigating and dealing with deviations in the Quality Assurance area:- Implementation of the Continued Process Verification study (Phase 3)- Restructuring the statistical evaluation of the Validation and Quality Assurance sectors- Optimization of costs related to Process Control samples for the Sterile Powders Production line.

Toledo, Paraná, Brazil

Process Validation Analyst with a focus on Continued Process Verification (CPV). The main activities carried out include:- Preparation of risk analyses, protocols and reports for Process Validation and Continued Process Verification studies (Phase 2 and Phase 3);- Application of statistical tools for Phase 2 and Phase 3;- Investigation and treatment of deviations from Phase 2 and Phase 3 studies;- Monitoring production processes on the oral solids, liquids and semi-solids lines;- Training in the use of statistical tools applied to the pharmaceutical industry.

Toledo, Paraná, Brasil

Process Validation Analyst with a focus on Process Validation, Holding Time studies and Continued Process Verification (CPV). The main activities carried out include:- Preparation of risk analyses, protocols and reports for Process Validation, Holding Time and Continued Process Verification studies (Phase 2 and Phase 3);- Application of statistical tools for Phase 2 and Phase 3;- Investigation and treatment of deviations from Phase 2 and Phase 3 studies;- Monitoring production processes on the oral solids, liquids and semi-solids lines;- Training in the use of statistical tools applied to the pharmaceutical industry.

Toledo E Região, Brasil

Intern in the Quality Assurance area, in the Process Validation and Cleaning Validation sector, monitoring different stages of the production process of solid, liquid and semi-solid medicines, in-depth study of statistical process and quality control, collections and carrying out other activities pertinent to cleaning validation, as well as bibliographical reviews and study of RDC No. 301/2019, IN No. 47/2019, RDC No. 200/2017 and RDC No. 73/2016, ISO 9000, 9001 and 9004 standards.

Toledo E Região

Statistician with a focus on preliminary data analysis, seeking to generate insights for client companies. Also works with the algorithms team to develop algorithms with more assertive forecasts.

Toledo E Região, Brasil

Took part in the paid monitoring program in the Probability and Statistics subject, developing activities with the aim of helping to fix the content for students in the Engineering classes, in the concepts of measures of central tendency (MTC), measures of dispersion (MD), statistical process control (SPC), hypothesis tests (HT), confidence intervals (CI), analysis of variance (ANOVA) and simple linear regression (SLR).

Master Black Belt, Master Black Belt In Lean Six Sigma

Postgraduate Lato Sensu - Specialization, Quality Management And Regulatory Affairs

Postgraduate Lato Sensu - Specialization, Statistics And Fundamentals Of Data Science

Graduation, Bioprocess And Biotechnology Engineering