Analysis of raw materials, intermediates, APIs, IPCs, cleaning, stability and validations of new analytical methods. Drafting in English of protocols and reports for the validation of analytical methods and analytical activities related. Compilation of logbooks in English to accurately document the work process and results of tests performed in compliance with cGMP requirements. Manage and carry on laboratory investigations in case of OOS, OOE, OOT and deviations, in collaboration with other functions (as Production, QA and R&D). Train QC personnel on the use of Chromeleon 7.2 SR 5 CDS and the application of new analytical methods.

Quality control on finished drugs and related production intermediates (granules, tablets, soft capsules, suppositories, ovules, sterile solutions). I took part in the annual Lean Lab project as a supervisor for laboratory rearrangement and instruments management. Compilation of logbooks in English to accurately document the work process and results of tests performed in compliance with cGMP requirements. Manage and carry on laboratory investigations in case of OOS, OOE, OOT and deviations.

Quality control on finished drugs (cremes, tablets, suppositories, syrups, non-sterile solutions).Compilation of logbooks in English to accurately document the work process and results of tests performed in compliance with cGMP requirements. Writing and reviewing of “quality product review” using SAP. Scheduling stability studies and trend evaluation.