Michele Marques S. Oliveira Email & Phone Number

Estados Unidos

Ethicon Inc - San Angelo TexasExternal audit/inspection readiness and management; Internal Audit Program and Management Execution; Metrics Collection and Reporting; Implementation of External Standards and Regulations; Site Management Review and Data Review Board.

Guarulhos, São Paulo, Brazil

People management; Responsible for Quality and Compliance for Medical Devices Distribution Center, Internal Audits, Technical Responsible of the site, projects related to the site, Cross Sector Brazil and LATAM, always ensuring compliance with J&J policies and procedures and local regulations.

São José Dos Campos, São Paulo, Brasil

Distributors and suppliers management; Quality Auditor (ISO 9001:2015 and ISO 13485:2016);Support to Equipment division area; Commercial contracts (QA approval and review); Cold chain Product release; Support in Health Authorities inquiries; Post Market Surveillance process

São José Dos Campos, São Paulo

Quality Auditor (ISO 9001:2015 and ISO 13485:2016); Supports Internal and External Audits; Responsible for Distributors and suppliers management / Purchasing Control process; Analysis and release Cold chain products; Responsible for support in Health Authorities inquiries on customs; Quality oversight of the equipment division area; Product Complaints; Post Marketing Surveillance; Quality responsible for Material Master Data.

Brasil

Work in Quality operations: Review manufacturing documents(filling and packaging process), inspection of production lines, Qualification of operators; Audits, Investigations of nonconformities; Management of reference samples; Development of standard operating procedures; Monitoring of pilot batches (related to technology transfer or change controls ) and Support initiatives to inventory reductions.

Suzano - Sp

Professor in the following subjects: Chemistry, Good Laboratory Practices, Techniques of Experimental Chemistry and Inorganic Chemistry, during maternity leave teacher.

Assessment lots of packaging materials, raw materials and products; Responsible for approving batches of packaging materials and semi-finished products; Investigating complaints and deviations; Evaluation and implementation of change control; Knowledge Proof Reader solids in the system (reading text); Comprehensive knowledge of current Good Manufacturing Practices; Conducting technical visits and audits of suppliers of packaging materials and raw materials and support to the area quality assurance audits to service providers; Preparation of performance reports annual suppliers; Development Agreements Quality Technicians with suppliers and service providers; Support the implementation of enterprise systems and global quality standards (SQA) Management of materials related to destruction and simple disposal of waste (products, materials packaging, waste production); Leadership productivity projects and participation of Six Sigma projects.

Conducting sampling and inspection of materials; Conducting analysis of raw materials in the system NIRS - Near Infra Red Spectrophotometer; Conducting analysis of packaging materials, text analysis system Proof Reader, Reading data from temperature recorders; Support receiving area, contacting suppliers and taking other necessary actions in case of receipt of materials or deviation with features that do not meet specifications and quality attributes; Preparation and review of operational procedures, protocols, equipment qualification, process validation protocols; Instructor in specific training for employees of the department, to other areas of manufacturing and suppliers and applying concepts of GMP; Conducting technical visits to suppliers; Development of productivity projects.

Support quality assurance area; Evaluation and conference documentation, sample retention, analytical results of the production process, packaging material and Finished Products Imported; Preparation of reports for analyzing the products approved by Quality Assurance, Preparation and Control Terms guard; Conference reconciliation forms of raw materials; Instructor training in the area of Quality Assurance, Monitoring the process of refrigerated materials. Monitoring of production processes; Review validation protocols; Support GMP Training area.

Support for the Center for Continuing Education, which manages the area courses and lectures for pharmacists, pharmacies Notifying the Program focused on training pharmacists, enabling them to receive and notify adverse reactions and quality deviations of drugs; Responsible for contacts with speakers and pharmacists enrolled in courses; Participation and preparation of minutes of meetings of partnerships in courses.

Master Of Business Administration - Mba, Engineering/Industrial Management

Vacation English, I Have Studied English For 4 Weeks In Philadelphia - Eua

Bacharel Em Farmácia, Pharmacy