Dipl.-Ing. Susanne Pucher
Angestellt, Head QA Technical Research&Development, Novartis
Langkampfen/Schaftenau, Österreich
Werdegang
Berufserfahrung von Susanne Pucher
Bis heute 4 Jahre und 7 Monate, seit Dez. 2019
Head QA Technical Research&Development
Novartis
Leading the QA dpt. for Technical Development Ensure Quality and QA oversight for activities during manufacturing/testing/release of clinical Biologics/Biosimilar including development/transfer/approval of source documents for the registration process/launch Ensure all aspects of the development process comply with cGMP and internal/external regulatory requirements Represent development function towards Health Authorities Implementation of Novartis strategic vision and Quality management system
Coordination, performance and supervision of GMP-Compliance activities on site (Drug Substance Schaftenau) with a team of compliance specialists. Strong collaboration with Quality Assurance, production and other departments (e.g. development, IT, HSE, Engineering...) to drive for improvement of quality beyond compliance.
4 Jahre, Jan. 2015 - Dez. 2018
Quality Site Project Coordinator
Sandoz
Coordination of Site wide projects for 4 Business Units
2 Jahre, Jan. 2013 - Dez. 2014
Quality Systems & Compliance Manager
Sandoz GmbH
Change Control System, Equipment Qualifications System, Maintenance Systems, Cleanroom Qualifications System, Autoclave validation System, Project Management
10 Monate, März 2012 - Dez. 2012
Head Engineering Processes
Sandoz GmbH, Kundl, Austria
Design the group for engineering processes after re-organisation (e.g. Asset Care Management), develop knowledge management for engineering standards, provide technical expertise and knowledge to plant engineers, manage engineering network across the company
4 Jahre und 9 Monate, Juli 2007 - März 2012
Head Engineering Compliance and GMP-Services
Sandoz GmbH, Kundl, Austria
Set-up of a compliance group to cover main engineering compliance categories within the company (automation, calibration, equipment qualification, change control, maintenance, etc.), Enhancement of measuring group for clean rooms (re-)qualification (particle count, velocity, pressure, temperature etc.)
5 Jahre und 2 Monate, Mai 2002 - Juni 2007
Head of GMP-Compliance for Automation Systems and GMP Services
Sandoz, GmbH, Kundl, Austria
Responsible for qualification procedures for automation systems, System owner for production calibration system, Head of measuring group for autoclave and refridgerator validation
2 Jahre und 11 Monate, Mai 1999 - März 2002
Qualification Engineer for Automation systems
Biochemie GmbH, Kundl, Austria
Lead of qualification project for API-plant automation system, integration of GAMP into qualification system for automation systems
3 Jahre und 4 Monate, Jan. 1996 - Apr. 1999
Quality Coordinator Engineering
Biochemie GmbH, Kundl, Austria
Establish quality coordinator's role in Engineering department: Responsible for GMP Compliance of engineering systems and services
5 Jahre und 6 Monate, Juli 1990 - Dez. 1995
Project Engineer (pharmaceutical plants)
Biochemie GmbH, Kundl, Austria
Planning of pharmaceutical API-plants, waste air treatment, biopharmaceutical plant up to 20 MEUR
Ausbildung von Susanne Pucher
5 Jahre und 11 Monate, Sep. 1984 - Juli 1990
Verfahrenstechnik / Process Engineering
Technical University Graz , Austria
Chemieanlagenbau/Process Plant Engineering
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen