Pharmaceutical Sciences
Global

Pharmaceutical Sciences Experts

Carla Cristina G Chimikus Mugarte

Associate Director
Pharmaceutical
Shire
Brazil

Biography

A GMP/GDP Subject Matter Expert with excellent interpersonal skills and over 23 years of diverse experience in the pharmaceutical industry. Quality Assurance for both commercially available and investigational products, auditing, qualification, validation, project management, budget control, line management, training, presenting and commercial & legal negotiation; Oversee the Latin America Quality Assurance for commercial operations including transportation management, and controlled temperature distribution for cold chain and controlled product lines within the Latin America and distributed from the Latin America; Active participation in product launching in the region interacting with commercial group and Technical departments. Providing Quality Assurance related inputs to the Business Case construction; International Certification in Lean Six Sigma; Knowledge of the national pharmaceutical legislation, laws and regulations; Controlled Substances, medical devices, plasma derived and biopharmaceutical products Subject-Matter Expert; Experience in national and international auditing such as ANVISA, COFEPRIS, ANMAT, INVIMA, DIGEMID, ARCSA and FDA;

Research Interest

Pharmaceutical

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