Dr. Christa Nachbagauer

1. QC contact and team member in technical project teams; 2. Responsible for QC strategy in assigned projects; 3. Maintains project analytical quality overview; 4. Overall responsibility for method validation/transfer to/from other labs; 5. Writes stability protocols and reports; 6. Ensures overview over the stability behavior; 7. Reviews technical submission documents from Reg-CMC, provides answers to HA questions; 8. Owner of project-related TQW/AQWA cases

Key words: Managing and scientifical support, as well as hands on in a QC-lab specialized in Endotoxin tests, LER studies, Glucan studies; handling of OOS/OOE and deviations in a GMP environment

Planning, implementation, evaluation, documetation and interpretation of Microbial enumeration tests - testing the drug substances for specified microorganisms with alternative microbiological procedures according to Pharmacopeial conventions; identification of microorganisms; handling of deviations and OOE/OOS events

Validating and optimizing HPLC/UPLC and GC methods within the GMP guidelines; planning, implementation, evaluation, documentation and interpretation of analytical methods as support of the production of drug substances; organizing and coordination of everyday lab business; training of the analytical employees in new methods and techniques

Characterisation of the Methyltransferase Moiety of the Human Mitochondrial RNase P.

Comparative biochemic studies of uterine flushings from pregnant and nonpregnant mares during maternal recognition.

Biochemie, Molekularbiologie

Biochemie, Zellbiologie, Molekularbiologie