Carla Sanguetin
Quality Systems Specialist @Forge Biologics
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WORK HISTORY
Quality Systems Specialist @Forge Biologics
Currently working as Quality Systems Specialist at Forge Biologics in the Quality Management Department. • Develop, review and implement Quality Systems procedures, work instructions and training materials. • Direct involvement with Veeva Vault modules implementation and module designs. • Project lead for Internal Audits program implementation and current Lead Auditor performing Internal Audits. • Work with cross-functional teams to implement Quality Risk Management Program. • Inspection Readiness Trainer engaging with new hires during onboarding training. • Authorship of the internal Area Ownership Program in collaboration with Regulatory & Compliance and in partnership with Manufacturing Operations, QC Laboratory and Warehouse & Distribution to facilitate organizational strategy and inspection readiness mentality. • Support to Regulatory Inspections, Consultants and Client Audits • Authorship in collaboration with Regulatory Affairs to set up and maintain the facility Site Master File.
EDUCATION
Universidade Estadual Paulista Júlio de Mesquita Filho
Bachelor Degree in Environmental Chemistry, Chemistry
Purdue University
Master of Science - MS, Biotechnology Innovation & Regulatory Science
ETEC "Prefeito Alberto Feres"
Technical Qualification in Chemistry, Chemistry, Honor Student
University of Portsmouth
Bsc (Hons) Marine Environmental Science, Marine Environmental Science
ABOUT CARLA SANGUETIN
Quality professional with over five years of experience in compliance, operations, quality systems and background in analytical laboratory settings and cGMP practices applicable to Pharmaceutical, Biotechnology and regulated industries; bachelor’s degree in Environmental Chemistry from the Sao Paulo State University – Brazil. I am focused on inclusive culture, continuous improvement initiatives, self-management, accountability and collaboration. Recognized as a leader and reliable partner with the ability to listen, connect with cross-functional teams and influence stakeholders in a fast paced and continuously changing environment.
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