Bachelor of Chemistry and Biochemical Pharmaceuticals, with extensive technical and regulatory knowledge: physical-chemical testing, chromatographic techniques, environmental and microbiological monitoring, stability study, technical review of (DMF) and fallow up with manufacturers. Maintenance, implementation and optimization of quality systems ISO 9001, ISO 14971, ISO 13/485, FMEA risk management (RDC 16/2013) / RDC 60/2014, RDC 73/2016, RDC 57/2009), RDC 45 / 2012, RDC, RDC 166/2017, RDC 53/2015, GAMP 5). Yellow Belt Certification - Six sigma & Lean Manufacturing in continuous improvement, cost reduction and waste reuse. Technical Staff Member for the elaboration of Protocols and Master Validation Plan for the following items: cleanliness, analytical methodology and process water systems / HACCP Hazard Analysis Critical Control Point Study Development / Process Maps, Critical Thinking Continuous Process Verification / Plug & Produce Process Automation by INSPER. Commercial technical support for Healtcare and Personal Care Products. Expertise in Analytical Drug Development at the University of São Paulo. Leader Training by SBC - Brazilian Coaching Society. MBA in Pharmaceutical Biotechnology from Merck Biopharma Academy.
Listed skills include Metodologia Kaizen, Seis Sigma, Capa, Norma Iso 9000, and 20 others.