Luca Guidetti
at Eurofins BioPharma Product Testing Italy- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Experience
-
Eurofins BioPharma Product Testing Italy
-
Italy
-
Pharmaceutical Manufacturing
-
300 - 400 Employee
-
-
Jul 2022 - Present
-
-
-
Oct 2020 - Jul 2022
GLP Microbiology Laboratory Study Director at Eurofins Medical Device Business Unit. RESPONSIBILITIES:- Client consultation with the aim to provide on assay design strategies for projects;- Check the scope of work and budget accurately to achieve client expectations at all times;- Scheduling of laboratory analysis;- Data analysis, QC and client report generation for on-time data delivery;- Develop and maintain Standard Operating Procedures and QC parameters for all assays according to the regulatory requirements (ISO 17025 and GLP);- Monitor if the projects are conducted in accordance with set global standards and procedures; - Complete and archive study files to pass prevailing regulatory inspections;- Evaluate existing data management and reporting systems and provide strategic input;- Continue to develop and implement cost improvement and efficiency plans to improve service delivery performance, efficiency, throughput, flexibility, and scalability;- Provide support to sponsor and internal audits;- Provide cross-functional support to other departments as required. Show less
-
-
-
Nov 2016 - Oct 2020
Quality Control Microbiology Analyst at Eurofins Medical Device Testing Laboratory.TECHNICAL SKILLS:- Evaluation of the microbial load (Bioburden Test - Membrane Filtration Method and Inclusion Method);- Determination of the total aerobic microbial count (TAMC) and total combined yeasts and molds count (TYMC);- Characterization of differentiate bacterial species (Gram staining); - Evaluation of antimicrobial activity of a product over time (Challenge Test);- Bioburden method validation; - Evaluation of the presence of bacterial endotoxins (LAL Test - Chromogenic method);- Sterility Test (Direct Inoculation Method and Steritest System Method);- Germ proofness assay in wet and dry conditions;- Microbial ingress analysis- Environmental controls (SAS, Exposure plates, Contact plates). Show less
-
-
-
Biologici Italia Laboratories S.r.l.
-
Italy
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
QC Microbiology Laboratory Analyst
-
May 2016 - Nov 2016
Stage of six months as Quality Control Analyst at Microbiology Laboratory in Biologici Italia Laboratories S.r.l. TECHNICAL SKILLS: - Evaluation of the presence of bacterial endotoxins (Gel Clot LAL Assays); - Evaluation of the microbial load (Bioburden Test - Membrane Filtration Method); - Sterility Test (Steritest System Method); - Dosage of antibiotics; - Environmental controls (SAS, Exposure plates, Contact plates). IT SKILLS: - SAP software Stage of six months as Quality Control Analyst at Microbiology Laboratory in Biologici Italia Laboratories S.r.l. TECHNICAL SKILLS: - Evaluation of the presence of bacterial endotoxins (Gel Clot LAL Assays); - Evaluation of the microbial load (Bioburden Test - Membrane Filtration Method); - Sterility Test (Steritest System Method); - Dosage of antibiotics; - Environmental controls (SAS, Exposure plates, Contact plates). IT SKILLS: - SAP software
-
-
-
Università degli Studi di Milano
-
Higher Education
-
700 & Above Employee
-
Master Thesis Student
-
Oct 2014 - Dec 2015
Internship at Caterina La Porta's laboratory (Molecular Oncology Laboratory) working on different projects. In particular, the purpose of my thesis has been to investigate the effect of two drugs, which are widely used in clinical treatments of hypercholesterolemia, on the level of cholesterol and on vesicular trafficking using two different approaches: HeLa cells as in vitro model and mouse seminiferous tubules as ex vivo model. Internship at Caterina La Porta's laboratory (Molecular Oncology Laboratory) working on different projects. In particular, the purpose of my thesis has been to investigate the effect of two drugs, which are widely used in clinical treatments of hypercholesterolemia, on the level of cholesterol and on vesicular trafficking using two different approaches: HeLa cells as in vitro model and mouse seminiferous tubules as ex vivo model.
-
-
-
Best Union Company S.p.A.
-
Rho Fiera Milano and Fiera Milano City.
-
Steward
-
Apr 2013 - Nov 2015
Occasional commitment as responsible of reception of the public and the maintenance of safety in fairgrounds. Occasional commitment as responsible of reception of the public and the maintenance of safety in fairgrounds.
-
-
-
Adamis Group Italia
-
Italy
-
Cosmetics
-
100 - 200 Employee
-
Sales Promoter
-
Apr 2013 - Oct 2014
Sales Promoter of products dedicated to health care and well-being. Work performed in perfumeries located in the center of Milan or in the surrounding areas. Sales Promoter of products dedicated to health care and well-being. Work performed in perfumeries located in the center of Milan or in the surrounding areas.
-
-
Education
-
University of Milan
Master's degree, Biology Applied to Research in Biomedicine -
University of Milan
Bachelor's degree, Biological Sciences -
I.T.C Primo Levi Bollate
High school diploma, Science and Technology