About 20 years of experience in the pharmaceutical industry
Having worked in Germany, the United States, and Brazil in functions of
Pharmaceutical Operations - Quality Control, Production, Company Headquarter, and Quality ManagementProven expertise in processes around Production and Quality Management Systems of small molecule solid/liquid oral dosage forms and Inhalation
Quality Management Systems:
General quality systems, FDA, EMA, ANVISA Regulation
Quality Risk Analysis and Risk Management, Investigation, Deviation, CAPA, Change management
Remediation of audit observations, 483, warning letters
Quality control and analytical development laboratories
Review and optimization of all relevant business processes
Process analysis and optimization with many tools (FMEA, SIPOC, DMAIC, 5S, etc.)
Creation and implementation of metric systems and monitoring of performance
Management reporting systems
Helping business owners to strengthen a solid foundation and business strategy so they can be successful. Support in knowing the requirements to improve compliance, processes, productivity, strategy, and company culture to grow and develop the organization.
Services can be provided in English, German, and Portuguese.