Jose Luiz Zanatta Junior Email & Phone Number

- Spearhead of the Quality Operation for all pharma dosage forms, liquids, semisolids, solids, injectable, of small (synthetic) and large (biologics) molecules and active pharmaceutical ingredients in 11 countries (Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Ecuador, Mexico, Paraguay, Peru, Uruguay) and leadership of third parties/service providers in CENAM, Luxembourg, Germany, and United States.- Responsible for the creation and implementation of a Global Quality System compliant to Health Authorities requirements, unified, harmonized on all affiliates with Policies and System Software Control for the management of local and global KPIs to drive the company business and strategic planning.

Guarulhos, São Paulo

- Manager of Quality Assurance, Validations and Quality Control team, 130 employees. - Responsible for the GMP routine production of solids, liquids, and semi-solids drug products, in license, QC physical-chemical and microbiological analyzes for batch release. - Responsible for process validation (registration and post-approval changes), cleaning validation, holding time, qualification of equipment and utilities. - Management of black belt process improvement projects, Quality by Design with PAT. - Member of the team responsible for international supplier qualification for drug products, drug substances, excipients, working on pre-remediations for GMP certification.

São José Dos Campos, São Paulo, Brazil

- Coordination of a team of 7 people responsible for the GMP routine production of liquid and semisolid consumer products. - Responsible for process validation, cleaning, holding time and purified water system qualification activities. - Responsible for managing quality indicators: deviations, CAPA, customer complaints. - Responsible for audits from the local Health Authority and Johnson & Johnson Corporate.

Graduation, Pharmaceutical Technology

Lean Six Sigma Black Belt

Especialização Em Administraçao Industrial