DOUGLAS DE OLIVEIRA PEDRO
San Diego,CA
Summary
Results-driven Analytical Validation Analyst with extensive experience at Pfizer, specializing in method validation and quality control. Proven expertise in HPLC operation and statistical analysis, complemented by strong problem-solving abilities. Successfully led investigations into out-of-specification results, ensuring compliance with regulatory standards and enhancing product quality. Collaborative team player dedicated to continuous improvement.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Analytical Validation Analyst
Laboratory Pfizer Ltda.
São Paulo, Brazil
2019.08 - 2022.01
Experienced in validation, transfer, and verification of analytical methods using HPLC, UPLC, ICP, and spectrophotometry. Skilled in bibliographic research, protocol/report preparation, statistical analysis, and spectral homogeneity evaluation. Provides training, conducts analytical tests, supports OOS investigations, and operates Agilent and Waters HPLC/UPLC systems with Empower 2.0 and LIMS.
Analytical Validation Analyst
Eurofarma Laboratory Ltda.
Sao Paulo, Brazil
2017.09 - 2018.11
Experienced in stability study analysis, investigating and resolving OOT/OOS results, and maintaining study schedules per RDC 45/2012. Proficient in Labware LIMS, analytical validation (RDC 899), and equipment qualification (RDC 17/2010). Skilled in HPLC, UPLC, GC, ICP-MS, and AA for physico-chemical analyses and documentation.
Analytical Validation Analyst and Stability
Laboratory Pfizer Ltda.
Sao Paulo, Brazil
2015.01 - 2017.01
Experienced in stability study analysis, evaluating results critically and resolving out of specification issues. Manages stability schedules per RDC 45/2012. Proficient in Labware LIMS, analytical validation (RDC 899), and technology transfer. Skilled in equipment qualification (RDC 17/2010) and operation of HPLC, UPLC, GC, ICP-MS, and AA for physico-chemical analyses.
Analytical Development and Quality Control Analyst
Libbs Pharmaceutical Ltda.
Sao Paulo, Brazil
2008.01 - 2012.05
Experienced in Analytical Development and Quality Control, performing physicochemical analyses, dissolution profiles, dosage, impurities, and residual solvent analysis (GC). Manages stability studies, reagent inventory, validation protocols, and analytical reports. Proficient in HPLC maintenance, SAP-based product release, and standardization of secondary standards for raw and finished products.
Education
Pharmacy and Biochemistry - Pharmaceutical Industry
UNIVERSIDADE PAULISTA (UNIP)
Sao Paulo07.2015
Skills
- Analytical methods
- Method validation
- HPLC/UHPLC - Agilent/Waters
- UV-Vis operation
- Quality control
- Validation protocols
- Process validation
- Documentation review
- Analytical skills
- Out of specification investigation
- Analytical troubleshooting
- Problem solving
- FLUENT IN Portuguese
- Problem resolution
- Analytical
- Flexible and adaptable
- Team collaboration
- Document preparation
- LIMS usage
- Assay validation
Languages
Portuguese
Native/ Bilingual
English
Professional
Certification
Agilet Technologies.
Description: Fundamentals of liquid chromatography (HPLC). Diagnostics and troubleshooting in liquid phase chromatography (HPLC).
Laboratory Pfizer Ltda.
Description: Data Integrity applied to laboratory routine. Data Integrity applied to out-of-spec results. Data Integrity applied to stability. Cleaning validation. Laboratory Information Management System (LIMS).
LIBBS Pharmaceutical Ltda.
Good Manufacturing Practices GMP, 06/01/10, Laboratory equipment (analytical balance, spectrophotometer, dissolutor and HPLC), 06/01/09
Timeline
Analytical Validation Analyst
Laboratory Pfizer Ltda.
2019.08 - 2022.01
Analytical Validation Analyst
Eurofarma Laboratory Ltda.
2017.09 - 2018.11
Analytical Validation Analyst and Stability
Laboratory Pfizer Ltda.
2015.01 - 2017.01
Analytical Development and Quality Control Analyst
Libbs Pharmaceutical Ltda.
2008.01 - 2012.05
Pharmacy and Biochemistry - Pharmaceutical Industry
UNIVERSIDADE PAULISTA (UNIP)