Andrea Azzini

Quality Control Supervisor @Jetpharma Sa

Coordination and oversight of QC laboratory main activities: Particle Size Distribution analyses on API, prior to and after micronisation process, using Malvern Mastersizer Sympatec & Morphologi instruments.Planning of secondary lab activities:API’s identity analyses (FT-IR, Melting Point, UV-Vis spectroscopy), microbiological monitoring of utilities (bacteria, yeasts and molds), spectrophotometric method development for cleaning validation, used for swab test in multi-purpose equipment.Other routine activities: data entry and review of Batch Records, laboratory’s logbooks, supervision of QC analysts in compliance to internal SOP and ICH guidelines (GMP, Data Integrity, CFR 21).Attendance for Audits in QC Lab by external customers and authorities (FDA, Swiss Medic); participation in drafting and revision of protocols and reports.