Veronica Bonazza
Quality Control and Analytical Development Manager @Vyriad
Signup · Get unlimited contacts
WORK HISTORY
Quality Control and Analytical Development Manager @Vyriad
Description • Established a QC laboratory to support product release. • Managing quality control testing • Coordinate and execute transfer protocol for clinical manufacturing from a Manufacturing Phase I site to Vyriad Phase II • Set up and execution of Environmental Monitoring Program and the microbiology laboratory • Set up and execution of media fill and gowning qualification programs for the Manufacturing team • Write, revise and approve documents such as SOPs and technical protocols and reports. • Established and running the Stability Program, Quality Control Sample Management Program, Incoming Raw Material Testing Program • Transfer of biological and chemistry methods such as: TCID50, RTqPCR, picogreen and ribogreen, ELISAs for impurity quantifications, WesternBlot, endotoxin, DNA size range, pH and conductivity, osmolality and other basic chemistry assays • Development of a new flow virometry method and mycoplasma testing • Write and execute Process Development methods and Process Validation programs • Contributed to develop the QMS system for investigations, CAPAs and other quality records • Supporting the leadership with strategic proposals, progress updates and presentations • Coordinate outsourced testing such as: sterility, NGS, cell and virus banks characterization
EDUCATION
Università degli Studi di Milano
Master's degree, Biotechnology
Università degli Studi di Milano
Laurea Magistrale, Biotecnologie
ABOUT VERONICA BONAZZA
Experienced Trilingual (English, Italian, French) Biologist with 15 years of experience working in the biotechnology industry: • Established Quality Control and Analytical Development laboratories. • Established and implemented Stability Programs, Incoming Raw Material testing, Release testing, Reference Standard testing, In-process testing, Process Validations. • Established programs for Environmental Monitoring, Aseptic Technique processing and Gowning qualifications • Established Microbiology laboratory and managed Outsourcing testing • Have managed and developed QMS systems, procedures, specifications, work instructions and quality documentations for Quality, Manufacturing and R&D (both clinical and commercial pipelines) • Have led product development, qualification and validation of Biochemistry Assays and method transfers among Sites. • Multiple years of direct supervisory experience, managing Biologists, Lab Technicians, Scientists • Have managed lab inspection preparations, inspection executions by Regulatory Agencies
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.