Dr. Heike Süß

Communication to authorities (FDA, CFIA, CTNBio) to assure the marketability of Evonik`s animal nutrition product portfolio. Elaboration of regulatory strategies and alignment with sales and marketing needs fitting into Evoniks global setup. Quality management and coordination of importer related FSMA activities.

Management and steering of dossier related work streams like coordination of scientific activities, product analytics, toxicological examinations and animal trials . Submission of white papers and GRAS notifications for Evonik`s animal nutrition products to FDA.

Preparation and submission of eCTD and NeeS dossiers for STADA`s pharmaceutical product portfolio to European authorities.

•Quality Management: writing SOPs, preparation for accreditation, ISO 15189, continuous process improvement •Proxy of the lab leader: organization of meetings, conflict management, lab organisation •Lab work: microbiological diagnostic, GLP •Project Management: feasibility studies, consultant, implementation of new systems, employee training, re-structuring the lab & the processes for quality assurance, internal product audits •Giving classes to medical students for hand hygiene

•Coordination of a German wide research project •Research and preparation of submissions to the Ethics Commity •Creation of brochures •Document management: maintenance of SOPs and relevant study documents, questionnaire digitization and failure check, data cleaning •Complaint management •Compliance: timeline-, data- and interface management •Quality assurance: conduction of ring tests (RiliBÄK) •Lab work: HPLC

• Regulatory and legal principles (ICH-GCP, AMG, GCP-V, MPG, Declaration of Helsinki) • Health economics • Submissions to authorities, managment of documents, reporting • Monitoring & quality assurance • Drug safety

• Composition of a quality management system according to DIN EN ISO 9000ff • QM methods and tools (FMEA, HACCP, CAPA etc.) • Project planning and steering using MS Project

• Typification of MRSA isolates using spa-technique & PFGE and creating respective databases • Laboratory and project management • Teaching medical students • Attending and presenting scientific results (talk and poster) on congresses

Anthropology, Paleontology and Zoology/Ecology