DOUGLAS DE OLIVEIRA PEDRO

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.

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.

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.

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.