CRISTIANO SILVA DE SOUZA
Kilkenny,County Kilkenny
Summary
Successful research and development professional equipped to lead and manage operations for pharmacy industry applications. Knowledgeable about technical constraints, current best practices and future trends. Decisive leader with people skills and attention to detail. Complex problem-solver with analytical and driven mindset. Dedicated to achieving demanding development objectives according to tight schedules while producing impeccable code.
Overview
7
7
years of professional experience
5
5
years of post-secondary education
Work History
Research and Development Analyst
União Química Farmacêutica Nacional
Guarulhos , Brazil
2020.12 - 2022.01
- Development of methods for new products, release of characterized batches, bibliographic surveys of new products
- Validation of methods according to RDC 166/17, operation of Empower software, knowledge of Agilent 1260 Infinity II chromatograph, Waters Alliance, previous knowledge of equipment maintenance
- Forced degradation study according to RDC 53/15, indicative of stability and mass balance, knowledge in RDC 318/19 on stability study of active pharmaceutical ingredient and medicines
- The goals are achieved within the determined deadlines, being delivered with quality and commitment.
Research and Development Analyst
Aché Laboratórios Farmacêutico S/A
São Paulo , Brazil
2018.08 - 2020.11
- Development of dissolution methods according to RDC 31/2010 and Guide 14 of 2018, solubility analysis according to technical standard n003/2013, comparative profiles between dosages and products
- Validation of methods according to RDC 166/17, domain of Open Lab software, knowledge of Agilent 1260 Infinity II chromatograph, previous knowledge of equipment maintenance
- Development of methods for the analysis of elemental impurities according to USP 232 and 233, operation of the Agilent 5100 ICP-OES, domain of the ICP Expert software, creation of methods for validating impurity analysis, sample preparation by digestion in micro- waves, validation of elementary impurity methods according to USP 1730 and RDC 166/17, preventive maintenance of microwaves and ICP-OES, responsible for the control of reagents, glassware, materials and standards used in the analysis of elemental impurities
- During the period in the company, I moved up in position in 1 year, due to the good performance I performed, I fulfilled all the deliveries and dedicated myself to the maximum for the final quality of the products.
Quality Control Analyst
Althaia Indústria Farmacêutica
São Paulo , Brazil
2017.02 - 2018.08
- Preparation of samples, solutions, operation of liquid chromatograph (Agilent, Hitachi), knowledge in HPLC UV and PDA, OpenLab (EzChrom)
- Execution of analysis of content uniformity, assay, related substances, degradation product, dissolution, Karl Fischer analysis, potentiometric analysis, spectrophotometer operation
- Analytical data records
- Investigation of out-of-specification results according to internal methodology
- Knowledge of RE 01/2005, RDC 53/2015, follow-up stability, accelerated stability study, long-term stability study, in-use stability study
- Elaboration of SOPs, reports, protocols
- Control of entry and exit of products in the stability chambers
- Conference of reports, training of new employees
- During the period in the company, I moved up in position in 10 months, due to the good performance I performed, I fulfilled all the deliveries and dedicated myself to the maximum for the final quality of the products.
Quality Control Analyst
Prati-Donaduzzi
Toledo , Brazil
2015.06 - 2017.01
- Sample preparation (Product, Stability, Cleaning Validation, Process Validation, Raw Material), solutions, liquid chromatograph operation, knowledge of HPLC UV and PDA, Empower 3, SAP, LIMS
- Analysis of content uniformity, dosing, related substances, degradation product, dissolution, Karl Fischer analysis, physicochemical and raw materials, performance of eppendorf and handstep pipettors, standardization and verification of secondary standards, responsible for weighing primary standards
- Analytical data records in the analysis reports in the SAP system
- Analytical data recording in the LIMS system
- Investigation of out-of-specification results according to internal methodology
- Responsible for input and output of products controlled by ordinance 344 in quality control, conference of reports, training of new employees.
Education
Bachelor of Science - Pharmacy
Centro Universitário UNA
Belo Horizone / Brazil 2009.07 - 2014.07
Skills
- Quality Control Management
- Computer proficiency
- Teamwork
- Problem-solving abilities
- Organization and people management
Languages
Portuguese
Native
English
Intermediate
Timeline
Research and Development Analyst
União Química Farmacêutica Nacional
2020.12 - 2022.01
Research and Development Analyst
Aché Laboratórios Farmacêutico S/A
2018.08 - 2020.11
Quality Control Analyst
Althaia Indústria Farmacêutica
2017.02 - 2018.08
Quality Control Analyst
Prati-Donaduzzi
2015.06 - 2017.01
Bachelor of Science - Pharmacy
Centro Universitário UNA
2009.07 - 2014.07
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