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
◊ Experience
in monitoring of clinical studies
◊
Languages:
German (native language),
English (fluent),
Italian
(basic)
Memberships
European QP Association
Austrian QP Association
Carinthia Economic Chamber
Standards
EU GMP
US FDA
WHO
PIC/S
Pharm. Eur.
USP
ICH
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