Sandra Kerstan

- Establishment of comprehensive risk overview related to Contamination Control and Quality Management Systems (QMS) - Definition of remediation approach to upgrade Equipment and QMS - Development of transformational roadmap - Definition of strategies and update of QMS, especially for Process Control Strategies (PCS) and Process Validation - Transforming new ways of working at Program - Coordination of external consultants

- Handling and management of raw materials, warehouse, tank farm, pest control - Contribution of expert knowledge to national and international inspections - Creation of validation protocols, validation reports and annual utility reports - Adapt ways of working by visualization and standardization according to Change Management Program - Project lead (e.g. for implementation of Audit Trail Review for critical computerized systems)

- Quality assurance in biotechnological API production - Handling and management of API upstream insulin process - Management of deviations, alert/action levels and change controls - Planning of process and cleaning validation procedures - Creation of annual product reports

- Characterization and development of prevention strategies of infections in an in vitro model - Establishment of the continuous in vitro reactor system - Investigation of the effect of different inhibitors and different media compositions in the system - Sample analysis and quantification by chromatographic methods, proteome analyses by mass spectrometry, transcriptome analyses using RNA microarrays

Mikro- und Molekularbiologie, Immunologie, Botanik