Silvia Biffi
Senior Quality and Compliance Project Engineer at PharmaProcess- Claim this Profile
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Bio
Experience
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PharmaProcess
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Italy
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Quality and Compliance Project Engineer
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Jun 2021 - Present
Pharmaprocess è una società di consulenza che opera in ambito farmaceutico. All'interno della BU di Quality and Compliance mi occupo sia di Equipment Validation che di Computer System Validation. Lavorando a contatto coi Clienti seguo sia attività di validazione programmata che attività strutturate per l'avviamento di nuovi reparti produttivi di farmici sterili e di principi attivi. Tra le attività che svolgo: - aiutare i clienti a definire le proprie richieste; - pianificare le attività del progetto con il cliente e con il team di lavoro - definire User Requirement Specification e Specifiche Funzionali - definire ed eseguire protocolli di DQ, IQ, OQ - mettere a punto documentazione di supporto (manuali tecnici, SOP) - investigare deviazioni e ottimizzare processi - supervisionare attività in cantiere Show less
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ProXentia
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Italy
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Biotechnology
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R&D / QA Biomedical
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Sep 2016 - Present
Proxentia is a start-up company specialized in diagnostic systems for the Food Industry. I was responsible for developing a new diagnostic device based on a proprietary technology and now I am responsible for improving internal processes to meet Quality requirements. Reporting to the CEO, my activities include: - investigate deviations and improve processes using Six Sigma tools; - CAPAs and SOPs for laboratory routine operations, calibration and validation of equipment, writing documentation and operative manuals; - coordinate teams of biotechnologists, engineers, IT to meet common deadlines; - collaborate with suppliers to ensure on time deliveries; - mentor young team members; - designing optical and mechanical systems and building prototypes; GMP; ISO 13485:2016; 98/79/EC; MDR 2017/746; MDR 2017/745 http://www.proxentia.com Show less
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Light & Colour Engineering
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Italy
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Research Services
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1 - 100 Employee
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Consultant - Lighting
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Sep 2018 - Present
Light & Colour Engineering is a company specialized in designing illumination systems based on LED light sources. My activities include: - optimizing optical devices; - performing validation analysis; Light & Colour Engineering is a company specialized in designing illumination systems based on LED light sources. My activities include: - optimizing optical devices; - performing validation analysis;
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R&D - Biomedical/Life science/Optics
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Apr 2013 - Aug 2016
I was responsible for experimental activities in two projects funded by the European Union. In the first project I had the responsibility to: - set up a new research laboratory focused on DNA Nanotechnology; - managing the budget; - implementing operating procedures; - selecting, installing and calibrating equipment; - supervising the activities of PhD students; In the second project I was responsible for: - developing a biosensor for monitoring the presence of bacteria in water; - coordinating with teams of biotechnologist and engineers to integrate the device in a portable unit for water quality detection; https://cordis.europa.eu/project/id/604241 www.napes.eu Show less
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Università degli Studi di Milano
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Higher Education
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700 & Above Employee
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Ph.D. student Biophysics/Biomedical/Optics
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Jan 2010 - Jan 2013
I started a research project to produce a biocompatible material based on DNA. My activities included: - developing a protocol to produce DNA nanoparticles; - measuring their phase diagram via light scattering and UV absorption; - working with leading companies in DNA synthesis and with molecular biologists to define specific protocols to treat the samples; I was into two internships, three months each, within the Liquid Crystal Materials Research Center (Colorado, USA) to study Liquid Crystals, and within the Soft Matter Laboratory (Fribourg, Switzerland) to study gels. Show less
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Università degli Studi di Milano
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Higher Education
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700 & Above Employee
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Test Engineer - Optics
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2009 - 2009
With the company SciTech Instruments (North Vancouver, Canada) I tested and implemented a scientific instrument for light scattering. My activity included designing and performing tests to identify mechanical malfunctions, testing the instrument controlling software, writing reports and technical documents. With the company SciTech Instruments (North Vancouver, Canada) I tested and implemented a scientific instrument for light scattering. My activity included designing and performing tests to identify mechanical malfunctions, testing the instrument controlling software, writing reports and technical documents.
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Education
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University of Milan
PhD student, Physics -
University of Milan
Master's degree, Physics -
Università degli Studi di Milano-Bicocca
Bachelor's degree, Physics