Roberta Genga
Head of Product Quality Expert & Qualified Person at Merck Healthcare
Based in Guidonia Montecelio, Italy
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Seniority
Other
Department
Other
Location
Guidonia Montecelio
Industry
Pharmaceutical Manufacturing
Company size
6.7K
Contact information
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r•••••••@merckgroup.com
Phone
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Background
About Roberta Genga
Qualified Person for Merck site -Quality Supervision of projects (early phase and commercial product)- Responsible to drive and supervise the QC analytical activities carried out by external contractors (Switzerland, UK, Korea, Russia, Germany, Lithuania, Iran), ensuring the interface between Merck and CDMO - Excellent knowledge of GMP guidelines, ICH and Pharmacopeia applied to analytical development, Technology Transfer and Quality Control QC-Troubleshooting of analytical methods of IMP molecules- Development of analytical methods to characterize recombinant proteins and monoclonal antibodies for therapeutic use- Improve scientific/technological approaches for advanced biopharmaceutical product - Preparing and review SOPs, Reports and Protocols, Change Control and Investigations, CAPA. Assuring the respect of the timelines
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