Ignacio Martin-Arjol

- CSA and Data Integrity guidelines: software periodic review, GAMP 5 2nd CFR 21 Part 11 for qc software - Review of executed batch records of chemical processes, API production - PQR’s edition (statistical analysis, Minitab): quality KPI’s and stability analysis - Management of Deviations, OOS’s, OOT’s, CAPA’s - Assessment and Implementation of Change Controls and CAPA’s - Review and approval of SOPs, protocols, check-lists - CSV: URS, RA, IOQ, PQ, Trace Matrix, SOPs - Supporting internal audits