Support and consulting in the area of aseptic manufacturing and microbiological laboratories (no performance of activities within manufacturing or the laboratory)
Review and ensure compliance with GMP requirements in production
Control, review, and documentation of work steps, review of processes in aseptic production.
Participation in the training and (re)qualification of aseptic production employees
Support for deviations in the area of aseptic filling: Conducting initial assessments Supporting the definition of the investigation strategy, including the evaluation of technical assessments within the scope of the investigation. Supporting the operations group in the deviation investigation, including the definition of appropriate corrective and preventive actions (CAPAs) to prevent the recurrence of a similar deviation. Reviewing the investigation reports in German...