Dr. Maja Raschke

Leading a Quality Team of 10 People experienced in Regulatory CMC, Change Control, GMP Liaison Activities and Technical Complaint Handling.

General Complaint Handling for Sterile and Solid dosage forms. Optimization activities for Complaint handling within the Team and with the Novartis Country Pharma Organizations. Escalation processes, involved in Health Authorities inspections. Teamlead for 8 employees.

Confirming GMP-Compliance of injectable drugs. Deviation handling. Technical Release activities. Support of Production Unit Prefilled Syringes and Autoinjector technology. Key position for in launch activities for sterile products (mainly prefilled syringes and Autoinjector). General support of teamlead.

Confirming GMP-Compliance. Assuring and controlling product, equipment and areal quality. Providing SOP's, manufacturing and packing instructions. Responsibility of deviation handling, change controls, process optimization and development, process and cleaning validation. Risk assessment. Coordination of project-specific interdisciplinary tasks. Preparation and escort inspections by Swissmedic and external Audits (supplier). Training and guiding staff members. Direct personal and financial responsibility.

Planning and preparing the sterile production of pharmaceuticals for human and animals. Coordination of working processes from raw materials 'til the delivery of products. Assuring and controlling product quality, writing SOPs, manufacturing as well as packing instructions. Training and guiding of staff members, solving problems, complying with GMP-conformity.

Independent planning and performing research, Establishing a method (genetic engineering) to over-produce vitamin B6, quantification of metabolites, activity tests, enzyme characterization, general DNA-, RNA-, protein methods (isolation, purification, quantification, complementation studies, establishing method for the in vitro biosynthesis of differently labeled forms of vitamin B6

Independent project managing - planning, conducting, evaluation of experiments, establishing and optimization of relevant methods, Radiation Protection Officer (2001-2005), identification of metabolites, in vitro and in vivo application experiments, literature searches, supporting supervision of group members, administrative tasks

Molecular Biology, Biochemistry, Microbiology, Genetic engineering, Vitamin biosynthesis, Over-production of vitamins, protein characterization, development of in vitro assays (activity tests, inhibition tests, application), chromatography (HPLC, purification of metabolites and proteins)

Fermentation, Prozess analytics, Material sciences, (Protein-) Biochemistry

Microbiology, Zoology, Botany, general lab practice