Our Profile – Who We Are

Theodor Langer

D_120123_061_copy2 BW

 Birgit Spitzer-Sonnleitner

P1020413_BW

Irmtraud Bernwieser

D_190104_052-2

Theodor Langer PhD has 13 years experience in the management of international pharmaceutical development projects. During his time at Baxter he was leading projects in all phases of drug development (research, development, preclinical, clinical, licensing, and launch).

He has achieved a PhD in Pharmacy and a Master in Toxicology from the University of Vienna. In addition he is a certified Project Management Professional (PMI).

Continuous learning and trainings in facilitation and communication, together with a high intercultural skill set, where the key to the successful lead of international, virtual teams.

For outdoor team activities he has an education as certified alpine instructor.

Furthermore he received trainings in Business Development and Portfolio Management.

Theodor Langer was teaching at the University of Applied Sciences, FH Krems the subjects of project management, pharmaceutical chemistry and toxicology.

e-mail: theodor.langer@tikopia-consult.at

Birgit Spitzer-Sonnleitner PhD has been working in  pharmaceutical quality control and quality assurance for 12 years.

Trained as a chemist with a PhD she started in quality control at Baxter, heading a laboratory. She later moved to quality assurance gaining experience in GMP auditing herself and in preparing and organising audits by regulatory bodies like the FDA or the AGES.

During her time at Nycomed in Linz she added APIs to her audit portfolio and became knowledgeable in supplier qualification.

Her experience ranges all through the production process from raw materials for API production to the distribution of finished product in companies making APIs, sterile drug product and biologics.

Birgit Spitzer-Sonnleitner is teaching Quality Mangement at the University of Applied Sciences, FH Krems and Quality Management in Laboratories at the University of Applied Sciences, FH Wels.

e-mail: birgit.spitzer-sonnleitner@tikopia-consult.at

Irmtraud Bernwieser PhD has more than 23 year in various areas in the pharmaceutical industry.

She has achieved a PhD in Analytical Chemistry at the University of Vienna. In addition she is a certified Project Management Professional (PMI) and has a certification as EOQ Quality System Manager and Auditor according ISO 9000 ff.

Irmtraud Bernwieser started in R&D Analytics and became Deputy Head of Quality Control at Nycomed Austria in Linz. After 5 years she moved to Baxter Healthcare in Vienna where she held various positions in Quality Management and Project Management over the following 18 years.

She has extensive experience in auditing according GMP/GLP as well as ISO standards. She participated in numerous regulatory inspections and customer audits at Baxter plants.

Irmtraud Bernwieser headed the Baxter Vienna Quality Systems team with special focus on validation, change management, complaint management, CAPA management, document data management and material qualification.

Irmtraud Bernwieser is teaching Project Management at the FH Campus Vienna.

e-mail: irmtraud.bernwieser@tikopia-consult.at