Simone Luciani
Qc - Microbiological Validation and Release at Thermo Fisher Scientific
Based in Frosinone, Italy
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Seniority
Other
Department
Other
Location
Frosinone
Industry
Biotechnology Research
Company size
99K
Contact information
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s•••••••@thermofisher.com
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Background
About Simone Luciani
More than five years of experience in the pharmaceutical industry that produce injectable sterile (In Process and Fill and Finish Aseptic filling line), consolidated experience in Quality Control (Release and Validation), with consolidated experience in cGMP. Experience during regulatory inspection. Digitization of the QC, to reduce the use of paper and increase the standard of the quality system. Validation of isolation systems, development of recipes and loads. FAT/SAT/IO-OQ-PQ isolator systems. Writing validation protocols, report and final method. Use of the biotrends system for incubation / movement management and sampling readings. Excellent knowledge of the LIMS, Sample Manager developer, TrackWise, Documentum, Biotrends system and empower.
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