Management
Thomas Pfeifer, PhD
CEO
Mag.Thomas Pfeifer, PhD
Thomas Pfeifer, who holds a doctorate in biochemistry, focused on basic research in the course of his master’s and doctoral thesis. In the course of this he was awarded the Scandinavian "Young Investigator Award" and he was able to publish his research results in several international publications. At that time he was already working on pharmaceutical products and researching possible active substances that could potentially reduce the cholesterol absorption in the blood and also the enterogenic biosynthesis of cholesterol. After 4 years of successful basic research, Mr. Thomas Pfeifer decided to end his university career and switch to the pharmaceutical industry. During this time he was able to gain experience in various areas of pharmaceutical production (vaccine production, classic pharmaceutical products and sterile production). The professional breadth that Mr. Thomas Pfeifer has gained over the years covers the entire spectrum of pharmaceutical analysis. After completing the university course in pharmaceutical quality management in Vienna, he was also registered with AGES as a qualified person in accordance with AMBO 2009 and Article 49 of Directive 2001/83/EC.
mail: thomas.pfeifer@apislabor.at
phone: +43 (0)463 20 35 00 - 10
Education
Karl Franzens Universität Graz
Biochemie und Molekularbiologie, 2007
Medizinische Universität Graz
PhD Program Molecular Medicine, 2010
Career
Head Analytical Quality Control at Novartis
Head Quality Control at Merck KgaA
Supervisor BSL3 Laboratory at Baxter AG
Systemadministrator and Project Assistant at Sandoz
Schooling
Lean Management, Management courses, qualified person (QP), Radiation Protection Officer.
Herwig Tiefenbacher, MSc
CEO
Mag. Herwig Tiefenbacher, MSc
After school, Herwig Tiefenbacher turned to the natural sciences with a commercial focus and completed his studies in functional plant physiology, bioindication and environmental monitoring at the Karl Franzens University in Graz. Core topics and focal points during his studies were basic research into physiological processes in higher plants, as well as basic research into secondary plant substances. As part of his diploma thesis, he researched the stress-physiological behavior of non-resistant Nicotiana tabacum (tobacco), infected with tobacco mosaic virus when treated with spagyric-homeopathically prepared Azadirachta indica (neem). Parallel to his university education, Mr. Tiefenbacher was able to gain professional experience in a pharmaceutical manufacturer, Spagyrik Pharma-Production GmbH. He completed his postgraduate master's degree in pharmaceutical quality management at the University of Vienna, which he completed with a master's thesis on the implementation of a new monograph in the German Homeopathic Pharmacopoeia. He was able to gain further experience in the pharmaceutical industry at Merck KGaA Spittal. As a qualified person, he headed the release office with a focus on the market release of medicinal products and dietary supplements. In addition to end product controls, quality assurance issues such as deviation or complaint management were also processed within the release office. After restructuring within the Quality Operations department, Mr. Herwig Tiefenbacher expanded his area of responsibility by taking over the Quality Assurance department.
mail: herwig.tiefenbacher@apislabor.at
phone: +43 (0)463 20 35 00 - 20
Education
Karl Franzens Universität Graz
Biologie (Schwerpunkt Pflanzenphysiologie), 2010
Universität Wien
Pharmazeutisches Qualitätsmanagement, 2015
Career
Head QA at Merck KgaA
Head Release Office at Merck KgaA
Head of Quality Control at Spagyrik Pharma GmbH
Head of Production at Spagyrik Pharma GmbH
Schooling
GMP auditor, qualified person (QP), various managment courses, various GMP and regulatory training.
Minela Cehic
Management Assistant
Minela Cehic
areas of responsibility
accounting
staff management
Quotations
email: minela.cehic@apislabor.at
phone: +43 (0)463 20 35 00 - 50
apis labor team
DI Christopher Hartl
Senior Lab Technician – Head of Laboratory
DI Christopher Hartl
Responsibilities:
Head of the Quality Control Laboratory and Qualified Person (per AMBO 2009)
Expert in HPLC, GC, and IC
Expert & Key User for Elemental Analysis (CHNS)
Method validations and transfers
Execution of routine analyses (HPLC, GC, IC, DC, titrations)
Analyses in accordance with ISO 17025
Key User for Chromeleon
email: christopher.hartl@apislabor.at
phone: +43 (0)463 20 35 00 - 30
Qualified Person (Trainee) – Quality Control Lead
Mag. Kartin Melischnig
Responsibilities:
Qualified Person in training
GMP Quality Management
Head of Quality Control Laboratory
Preparation and review of Standard Operating Procedures (SOPs)
Audit management
email: katrin.melischnig@apislabor.at
phone: +43 (0)463 20 35 00 - 30
Angelika Scherer
Lab Technician III
Angelika Scherer
Responsibilities:
Method development for HPLC and IC
Routine analyses (HPLC, GC, IC, DC, titrations)
Analyses in accordance with pharmacopoeias and ISO 17025
Instrument responsibility
Key User for Chromeleon 7.2
email: angelika.scherer@apislabor.at
phone: +43 (0)463 20 35 00 - 30
Lab Technician II
Lisa Jamnig
areas of responsibility
Expert in GC and classical wet chemistry methods
Expert in Elemental Analysis (CHNS)
Method validations and transfers
Routine analyses (HPLC, GC, IC, DC, titrations)
Analyses according to various pharmacopoeias
email: lisa.jamnig@apislabor.at
phone: +43 (0)463 20 35 00 - 30
Alina Müller
Lab Technician II
Alina Müller
areas of responsibility
Expert in GC, wet chemistry methods, and ICP-MS
Method validations and transfers
Routine analyses (HPLC, GC, DC, titrations)
Analyses in accordance with pharmacopoeias and ISO 17025
email: alina.mueller@apislabor.at
phone: +43 (0)463 20 35 00 - 30
Marion Benirschke
Lab Technician II
Marion Benirschke
Responsibilities:
Expert in GC, wet chemistry methods, and ICP-MS
Method validations and transfers
Routine analyses (HPLC, GC, DC, titrations)
Analyses in accordance with pharmacopoeias and ISO 17025
email: marion.benirschke@apislabor.at
phone: +43 (0)463 20 35 00 - 30
Elisabeth Andrej
Lab Technician II
Elisabeth Andrej
Responsibilities:
Expert in GC, wet chemistry methods, and ICP-MS
Method validations and transfers
Routine analyses (HPLC, GC, DC, titrations)
Analyses in accordance with pharmacopoeias and ISO 17025
email: elisabeth.andrej@apislabor.at
phone: +43 (0)463 20 35 00 - 30
Stefanie Husu
Lab Technician I
Stefanie Husu
areas of responsibility
Carrying out routine CHNS analyses
Carrying out routine analyzes (HPLC, GC, TLC, titrations)
Carrying out analyzes according to various pharmacopoeias and ISO 17025
email: stefanie.husu@apislabor.at
phone: +43 (0)463 20 35 00 - 30
Maria-Ana Creta
Facility Staff
Maria-Ana Creta
areas of responsibility
room maintenance
Waste Managment
apis labor quality assurance team
Larissa Blasch-Cirko, MSc
Quality Expert - Senijor Consultant
Larissa Blasch-Cirko, MSc
areas of responsibility
GMP Quality Management
SOP preparation and review
Audit management
Data integrity specialist
email: larissa.blasch-cirko@apislabor.at
phone: +43 (0)463 20 35 00 - 40
Quality Expert - Consultant
Beate Weinberger
Quality Expert - Consultant
Beate Weinberger
areas of responsibility
Qualified Person
GMP Quality Management
SOP preparation and review
Safety assessments and development
Audit management
email: beate.weinberger@apislabor.at
phone: +43 (0)463 20 35 00 - 40
Andrea Facko
Quality Assurance Specialist
Andrea Facko
areas of responsibility
Batch record review
GMP Quality Management
Preparation of Product Quality Reviews (PQRs)
SOP preparation and review
Audit management
LIMS expert
email: andrea.facko@apislabor.at
phone: +43 (0)463 20 35 00 - 40