Fabrizio Maniglio

Manage all incoming deviation and assign them to the team members. Manage the deviation team. Define priorities for the deviations. Lead the investigation into root cause. Investigate the impact on SISQP of the product. Identify the root cause(s) and define corrective and preventive actions (CAPA) together with the relevant functions. Write the deviation report in TrackWise. Responsible for the timely closure of the assigned deviation reports and related CAPAs.

Lead the investigation into root cause. Investigate the impact on SISQP of the product. Identify the root cause(s) and define corrective and preventive actions (CAPA) together with the relevant functions. Write the deviation report in TrackWise. Responsible for the timely closure of the assigned deviation reports and related CAPAs. Define criticality of devaitions Track recurrence and reoccurrence. Trend deviations and identify systemic issues.

Lead the microbial QC support for the chemical API production, including development/adaptation of methods, training and release analytics. Investigate and write deviations in relevant areas. Plan method validation, including the creation and completion of validation plans and reports Responsible for the safety concept of highly active - or sensitizing substances. Responsible for the temperature logging system for freezers and incubators.

Microbiology Immunology