Anna Katharina Resch

- Development of the validation strategy for systems and releases - Creation, review, and tracking of validation documentation throughout the lifecycle of LIMS/LES and releases - Advising and supporting the system development team to ensure adherence to applicable regulations and industry standards - Responsibility for continuous improvement of cross-departmental validation approaches - Implementation of the Agile Validation Process in the GCP laboratory environment

• Analysis of lab processes and requirements engineering • Management of Lab data flow maps in cooperation with lab personal and QA • Communication between lab responsible and software developers • System design and architecture • Management of validation efforts • Configuration and development of LIM-systems • Creation of SOPs, training material • System ownership of LIMS in regulated environment (GCP for labs)

- Life-cycle management of current LIMS (GCP for Labs) - Management of development and configuration activities of a new LIMS in regulated environment - Design, maintenance and documentation of individualized data management systems - Development of bioinformatic software for laboratory processes - Training of internal and external users of the LIMS

With focus on bioinformatic analysis