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Company Profile
 

 

S.B. PHARMA SUPPORT e.U. is an Austrian service provider, specialising in quality assurance / project management for the pharmaceutical industry.

Our range of services include the following:

   
  Quality Assurance
      Project Management
      Regulatory Compliance
   
  Clinical Research

My consolidated expert knowledge stems from 11 years of professional experience in the pharmaceutical industry at three of the “big players” and the qualification as Qualified Person [acc. to § 7 of the Austrian “Arzneimittelbetriebsordnung 2009 – AMBO 2009”, Federal Law Gazette II Nr. 324/2008].

Located in the heart of Austria with a good infrastructural junction to the airports of Klagenfurt, Graz, Ljubljana and Trieste the company is ideally situated for international collaborations.


Mission
Defining targets is only the start, to reach them requires a lot of effort. With the hands-on-mentality of my company we can reach these targets together.


About My Background
  Biologist
  Qualified Person since 2007
  more than 10 years professional experience, with special focus on GMP

 
Several years experience in GxP auditing in 19 countries all over the world
    (Europe, India, Japan, America, Oman, Vietnam, Russia, and many more)
 
Management experience as Head of Regulatory Compliance
 
Experience in all areas of quality assurance
 
Experience in TrackWise, SAP

 
Experience in GMP and software training
  E
xperience in monitoring of clinical studies

 
Languages: German (native language), English (fluent), Italian (basic)



Memberships
European QP Association
Austrian QP Associatio
n
Carinthia Economic Chamber



Standards
EU GMP
US FDA
WHO
PIC/S
Pharm. Eur.
USP
ICH

 

      Last update: 31.08.2015