Amanda Silva Email & Phone Number

Brazil

New Westminster, Bc, Ca

Richmond, British Columbia, Canada

· Assessing quality incidents like deviations, investigations, product complaints, CAPAs, risk assessment, and change controls. · Collaborating within cross-functional teams as R&D, Production, Sales, Planning, Regulatory, Business to solving problems, implementing improvements and identifying root causes. · Developing, implementing quality procedures such as, batch records, specifications of raw materials and final product, standard operational procedure.· Reviewing raw data including batch records and forms. · Supporting inspections and audits – Health Canada and FDA. · Implementing KPI’s to support key users with decision-making data.

North Vancouver, British Columbia, Canada

· Responsible for organizing medications and sending them to patients.· Responsible for mapping of process, identifying risks and elaboration of KPIs.· Provide product information, answered questions, and demonstrated the features of products.

Rio De Janeiro, Brazil

• Responsible for coordinating activities in relation to stability programs for both early-stage and late-stage products including coordinating and logging clinical batches for both release testing and stability studies, collaborating with internal and external partners.• Managing of holding time studies, production process, applied in different process as upstream, downstream and lyophilization.• Elaboration of protocols and reports with statistical analysis.• Technical response of costumer complains of vaccines.• Focal point to elaborate SOPs (standard operating procedures), specifications.• Elaboration of periodic product review for stability studies.• Technical support for technology transfer;• Analysis of CAPA (corrective action & preventive action), change control, risk assessments, investigations, and deviations.• Scientific document research in FDA and ICH guidelines.• Robust experience in receiving international GMP audits and inspection.

Rio De Janeiro

• Focal Point to plan and execute cleaning validation in the oral liquid area.• Elaboration of protocols and reports with data analysis.• Technical support to CAPA (corrective action & preventive action), change control, risk assessments, and deviation processes.• Team training following GMP standards and practices.• Experience in applying the risk-based approach throughout the validation lifecycle.• Robust experience in receiving international GMP audits and inspection.

Rio De Janeiro

• Performing analysis and processes data to support stability testing and analytical transfers using techniques as UV, HPLC, UPLC and GC.• Executing tasks by conforming to written procedures and protocols, recognizing deviation and out-of-specification (OOS) occurrences and system suitability failure as well as performing investigation as required.• Elaborating protocols and reports for technology transfer.

Rio De Janeiro, Brazil

• Conducting site selection for potential sites to evaluate their capabilities for conducting clinical trials.• Managing assigned study sites and networks, according to the monitoring plan and ICH.• Preparing clinical research material for sending to research centers and submission to regulatory agencies.

Rio De Janeiro, Brazil

• Performing analysis and processes data to support stability testing and analytical transfers.• Developing of new formulations.• Managing of stability studies.

Master Of Business Administration, Total Quality Management

• Monograph on utilization of Lean Office to improve industrial administrative processes.

Industrial Pharmacy, Industrial Pharmacy