-KPI’s reporting and data analysis -QMS analysis -Quality assurance on the shop floor sterile dosage forms-Active participation in Quality system processes, such as GMP (Good manufacturing practice) documentation management, change control, investigation, deviation, CAPA (corrective and preventative actions) measures-Investigating the deviation/nonconformities and summarize all data results in the report with a focus on product impact assessment-Defining CAPA measures, CAPA monitoring and efficiency-Root cause analysis-Customer complaints investigation-Participation in internal audits

Main tasks:-Maintaining up-to-date documentation on internal and external microbiological analyses-Data analysis of microbiological results in SAP-Writing of monthly, quarterly and annual reports-Management within the microbiology laboratory and quality control sector-Active participation and implementation of Proficiency Testing schemes in order to validate and improve existing internal methods and in order to validate the work of microbiological technicians-Development and improvement of plans for microbiological analysis of water, raw materials, semi-finished products and finished products in accordance with defined control and testing plans in accordance with ISO methods