Marcelle Moraes Email & Phone Number

United States

United States

California, United States

Responsible for keeping the Quality Management processes with high performance, in addition to promoting support for manufacturing process in order to ensure compliance with procedures. GMP and Process Validation. Leadership in the ISO 13485 implementation and certification project. Working on Quality and Regulatory aspects to ensure compliance with the Standards of the Regulatory Agencies for Medical Devices and Cosmetics in the US and EU. Review all processes, procedures and records against the requirements of ISO13485 and Title 21 CFR Parts 820.

California, United States

Restructuring of the quality management system.Development of KPIs for mapping activities and quality demands, for management reviews.Management of quality actions (CAPA, NCMR, Deviations).Review of processes, procedures and records against the requirements of ISO13485 and Title 21 CFR Parts 820.

Rio De Janeiro E Região, Brasil

Custody, control and conference of reports and general documentation of validation processes in analytical methods.- Elaboration, updating and revision of the Laboratory's Standard Operating Procedure.- Opening and closing of Corrective and Preventive Actions (CAPAS).- Conducting laboratory investigations, keeping track of time to complete the same.- Audits: Auditing of documents and internal processes related to the company's products. Participation in external audits monitoring and responding to items to the regulator;- Validation and development of analytical methods for drug release through HPLC analysis. National responsible in the company for the data collection project and risk assessment regarding metallic contaminants in the medicines produced by the company, according to the current guidelines (ICH-Q3D).- Regulatory Compliance Analyst, working for 1 year on changes to the registration and post-registration of medicines sold in the Brazilian market.

Rio De Janeiro E Região, Brasil

HPLC MS / MS Equipment Analyst: liquid chromatography in mass spectrometry (310-MS LC / MS and 320-MS LC / MS, API 4000, API 5500);Development of numerous bioanalytical methods for the extraction of drugs in biological matrices and the performance of said tests for the bioequiavalence of these drugs, validations of bioanalytical methods and analytical batches;Preparation, checking and auditing of analytical reports and standard operating procedures, together with quality assurance;Sample custody: responsible for understanding the reception, storage, distribution, aliquoting and disposal of biological samples, monitoring the temperature of their storage and preparing them for analysis;Bench analyst: responsible for preparing validations and analytical batches, preparing solutions, extracting drugs from plasma samples by liquid / liquid extractions or precipitation, handling small equipment, washing glassware;Elaboration and training of the practices required by the laboratory and restructuring of the model for reporting bioanalytical data that are sent to ANVISA's audit; Member of the team responsible for the bioequivalence of a new formulation of antiretroviral drugs.

Six Sigma Green Belt, Project Management, Certified

Project Management Essencials Certified, Project Management

Mba In Integrated Management System In Quality, Safety, Environment And Health - Qseh, Quality Control Technology, Início Do Curso Em Janeiro De 2015

Degree In Chemistry, Chemistry

Chemistry Technician, Chemistry