Dr. Stephanie Olbrich

Seniorberaterin, Projektleiterin, Stellvertretende Leiterin der Herstellung, Sachkundige Person nach Paragraph 15 Absatz 3a Nr. 6 AMG, Freigabeberechtigte Person für Wirkstoffe nach Paragraph 21 Absatz 3 AMWHV

Ensuring GMP compliance in batch production and testing; Responsible for DS Release in large scale production of API, Deviation and OOx management; Review and Approval of specifications, sampling instructions, test methods and other quality control procedures; Change Control; Participation in the creation and approval of validation, transfers and SOP, Management of project teams; Self-inspections, costumer audits and inspections by the authorities; Implementation of quality assurance task

Monitoring of the process parameters with statistical analyzes and creation of product-specific data trends (ongoing process verification); Management of projects for process optimization involving cross-functional teams / lifecycle management; Risk analyzes; prozess validation; process transfer; Escalation Management; Deviations and OOS/OOE handling; Preparation of internal and external audits; Review of dossier documents for submission of active pharmaceutical ingredients to authorities;

Method development for in-house synthesized intermediates and active substances (e.g. wet chemical tests, HPLC and GC); Validation of methods according to guidelines; Transfer of methods, Release analytics; Ensuring GxP operation in the laboratory; Qualification of laboratory equipment; GxP-compliant work and documentation of the results; Deviations and OOS managment; Control of analytical laboratory data; Leadership (team of up to 7 people) and Capacity planning

Preparation of the dossier for the authorities of active pharmaceutical ingredients; Coordination of analytical development activities with external partners; Creation of registration concepts for development projects and answering of deficiency letters; Coordination of work to define product specifications; Creation of analytical development, validation and stability reports; Ensure compliance with agency guidelines for product approvals

Thema der Dissertation: "Strukturuntersuchungen an biologischen Materialien mit Hilfe rasterkraftmikroskopiebasierender Nanotomographie" Abschluss: doctor rerum naturalium (Dr. rer. nat.)

Thema der Diplomarbeit: "Nanotomographie an Biomaterialien", Professur Chemische Physik