Luca Biondini Email & Phone Number

Barbengo, Canton Ticino, Switzerland

Work in the Chemical Analysis Laboratory of the Quality Control Department.Excellent knowledge of analytical techniques (HPLC, GC, UV-VIS, IR, TOC, Titration, Polarimetry, ...)Knowledge of chemical and physical analytical methods.Knowledge of cGMP and ICH guidelines.Handling and analyses of starting materials, bulk products, finished products, stability products.Sampling of raw materials and packaging materials.Handling of HPAPIs according to HSE procedures.Review of analitical raw data.

Taverne, Canton Ticino, Switzerland

Responsibility:Planning and feasibility of projects related to pharmaceutical forms.Analytical methods development.Validation of analytical methods according to Pharmacopoeias, cGMPs, ICH Q2 (R1) and internal SOP's.Preparation and revision of SOP’s.Use of HPLC and various instruments inherent in all analyses required.Contacts with suppliers, instrument technicians, instrumentation support companies.Contacts with external laboratories and companies in synergy with the QA / QPQuarterly, half-yearly or annual checks in relation to internal requirements relating to laboratoryinstruments.Standard purchase management, consumer products, laboratory-related tools.Management of the analytical requests with the Quality Control of Lagap SA.Respond to regulatory requests.Preparation of stability protocols and drafting of stability reports.Timing management in the execution of laboratory analysesProgramming of analytical activities during the Process ValidationAnalytical transfers: drafting of protocols and reports, analytical executionManagement of out of specification (OOS) data and deviations; classification of the analytical deviations.Preparation of the laboratory for the Self-inspection and cGMP inspections.Skills:Ability to manage a series of projects and initiatives simultaneously.Effective ability to manage the requests for both of chemical-physical and microbiological analyses.

Manno, Canton Ticino, Switzerland

Work in the Chemical Analysis Laboratory of the Quality Control Department.Experience and mastery in physical and chemical analysis techniques:-HPLC-UV / -RI / -DAD-DI / HS-GC-FID-UV-VIS-FT-IR-NIR-Titrino-Hardness testUse of various chemical and physical instruments:TLC, KF, Polarimetry, Texture test,Dissolution test, Disintegration test, Optical microscope, Digital density meter.Analysis of: raw materials, finished products, bulk products, holding time products and packaging materials.Analysis of cleaning validation samples.Preparation of analysis methods and specifications according to USP and Ph. Eur.Drafting of analysis sheets.Management and purchase of glassware and laboratory reagents.Verification of good functionality of laboratory equipments.Participation in Swissmedic and FDA inspections

Master'S Degree, Pharmaceutical Chemistry And Technology (C.T.F.), 99/110

Federal Diploma, Literary High School