Dr. Maja Raschke
Angestellt, Network Lead Regulatory, Change Control & Complaints, Novartis Pharma Stein AG
Stein (AG), Schweiz
Werdegang
Berufserfahrung von Maja Raschke
Bis heute 2 Jahre und 9 Monate, seit Okt. 2021
Network Lead Regulatory, Change Control & Complaints
Novartis Pharma Stein AG
Leading a Quality Team of 10 People experienced in Regulatory CMC, Change Control, GMP Liaison Activities and Technical Complaint Handling.
5 Jahre und 5 Monate, Mai 2016 - Sep. 2021
Network Lead Complaints
Novartis Pharma Stein AG
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.
3 Jahre, Mai 2013 - Apr. 2016
Senior QA Specialist
Novartis Pharma Stein AG
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.
2 Jahre und 10 Monate, Juli 2010 - Apr. 2013
Head of Sterile Department
Streuli Pharma AG
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.
11 Monate, Aug. 2009 - Juni 2010
Deputy Head of Sterile Department
Streuli Pharma AG
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
5 Jahre und 9 Monate, Sep. 1999 - Mai 2005
Research Assistant
Martin-Luther Universität Halle-Wittenberg
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
Ausbildung von Maja Raschke
3 Jahre und 11 Monate, Mai 2005 - März 2009
Biology
ETH Zurich, Switzerland
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)
6 Jahre und 2 Monate, Okt. 1998 - Nov. 2004
Bioengineering
Martin-Luther University Halle-Wittenberg, Germany
Fermentation, Prozess analytics, Material sciences, (Protein-) Biochemistry
1 Jahr und 11 Monate, Aug. 1996 - Juni 1998
Biology
Oberstufenzentrum Potsdam Mittelmark, Deutschland
Microbiology, Zoology, Botany, general lab practice
Sprachen
Deutsch
Muttersprache
Englisch
Fließend