Christoph Bartz

Negotiation of Quality Agreements regarding GMP related Services (e.g. manufacturing and testing of Cell Banks/API/Drug Product and stability studies)  Organisation & follow-up of GMP audits by customers & inspections by regulatory authorities QA Contact for customers regarding quality related aspects/issues/questions Ensurance of integrity, compliance, and scientific soundness of the entire OOS/OOE/OOT process Stability Studies of GMP Material, including review of raw data, stability plans and reports

ProBioGen - Quality Assurance & Compliance - QA Manager - Quality Agreements - Audits/Inspections - Customer Care/QA Contact  - Stability Studies of GMP Material:

Preparation, writing and review of GMP compliant documents (e.g. test records, test instructions, certificates (CoT/CoA)) Writing and review of SOPs. Review of records, raw data and protocols of GMP release tests, ongoing stability tests (GMP & non-GMP material) and ongoing qualifications of reference standards. Initiation, processing and support of Change Controls, Deviations and CAPAs. Management and organization stability studies, writing and review of stability study plans and capturing of KPIs.

QA activities at the locations CRS Berlin and CRS Kiel within the framework of clinical trials (phase I/II): Review of GCP compliant documents and raw data. Accompaniment and support of external audits and conducting of internal audits. Initiation, preparation and support of CAPA & Deviation reports. Writing and review of SOPs (working with electronic SOP System). Communication and qualification of subcontractors. Training of employees concerning SOPs and GCP.

Institute of Physiology: Regulation of vascular (lung endothelial) permeability by lysosomal trafficking. Research: - in vivo / in vitro experiments - human cell culture (incl. tranfections) - microscopy (intravital, TIRF, Confocal) Teaching: - physiology of respiration hemostasis anemia communication-interaction-teamwork (Doctor patient dialogue and anamnesis)

Institute of Biochemistry: Regulation of the Ubiquitin-Proteasome System (UPS) and the Proteasome Modules Research: -cell culture -(RNA) immunoprecipitation - protein purification -western blot Teaching: general lab methods (PCR, SDS-PAGE, western blot)