Dipl.-Ing. Florian Hackel
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Florian Hackel
- Bis heute 6 Jahre und 6 Monate, seit Jan. 2019
Senior Director, Head of Quality at Vienna site
Takeda
Senior Director – Head of Quality Vienna (organization with ~ 370 employees): • Responsible for Quality Assurance • Responsible for Release • Responsible for Complaint Management • Responsible for Quality System Execution • Responsible for Sterility Assurance level • Responsible for Inspection readiness • Responsible for the budget of the Quality Vienna organization • Responsible for the development of the Q Vienna organization • Responsible for the QC labs at the Vienna plant
- Bis heute 7 Jahre und 8 Monate, seit Nov. 2017
Senior Director, Head of Quality Vienna
Shire
Senior Director – Head of Quality Vienna (organization with ~ 300 employees): • Responsible for Quality Assurance • Responsible for Release • Responsible for Complaint Management • Responsible for Quality System Execution • Responsible for Sterility Assurance level • Responsible for Inspection readiness • Responsible for the budget of the Quality Vienna organization • Responsible for the development of the Q Vienna organization • Responsible for the QC labs at the Vienna plant
- 1 Jahr und 5 Monate, Juni 2016 - Okt. 2017
Director Quality Assurance
Shire
- 11 Monate, Juli 2015 - Mai 2016
Director, Quality Assurance
Baxalta
Director – Quality Assurance Vienna (organization with ~ 150 employees): Responsible for QA and release of the following products: Vaccines, Plasma derived products, Recombinant product, including Quality Systems (CC, CAPA, Complaints, Inspection readiness). Development of QA organization.
- 6 Monate, Jan. 2015 - Juni 2015
Director of Quality Assurance
Baxter in Österreich
- 3 Jahre und 3 Monate, Okt. 2011 - Dez. 2014
Senior Manager Quality Assurance
Baxter in Österreich
Manager II – Quality Assurance Vienna (organization with ~ 90 employees):
- 1 Jahr und 8 Monate, März 2010 - Okt. 2011
Junior Manager Quality Assurance
Baxter AG
Manager I – Quality Assurance, Pharmaceutical area Vienna plant (organization with ~ 35 employees):
- 4 Jahre und 2 Monate, Feb. 2006 - März 2010
Manufacturing Supervisor
Baxter in Österreich
Supervisor Manufacturing – Aseptic Processing (organization with ~ 6 employees)
- 1 Jahr und 3 Monate, Nov. 2004 - Jan. 2006
Manufacturing Specialist
Baxter in Österreich
Perform clean room monitoring in class C (physical and microbiological) • System Owner for cleaning validation in the pharmaceutical area • System Owner for physical clean room monitoring (SOP Owner) • CAPA and Change Control Owner, SOP creation • System Owner for aseptic awareness program including reduction of microbiological deviations • Presentation of systems during internal and external GMP inspections • GMP Trainer
- 1 Jahr und 7 Monate, Mai 2003 - Nov. 2004
GMP Operator
Baxter in Österreich
Perform clean room monitoring in class C (physical and microbiological) • CAPA and Change Control Owner, SOP creation, GMP Trainer
Ausbildung von Florian Hackel
- 5 Jahre und 11 Monate, Sep. 1998 - Juli 2004
Biotechnology
Universtität für Bodenkultur Wien - Vienna - Austria
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen
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