Dipl.-Ing. Susanne Pucher

I am happy that, after 34 year worklife journey , I found a way that serves the needs of my private life. I am looking ahead to retirement when I will be old enough.

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.

Coordination of Site wide projects for 4 Business Units

Change Control System, Equipment Qualifications System, Maintenance Systems, Cleanroom Qualifications System, Autoclave validation System, Project Management

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

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.)

Responsible for qualification procedures for automation systems, System owner for production calibration system, Head of measuring group for autoclave and refridgerator validation

Lead of qualification project for API-plant automation system, integration of GAMP into qualification system for automation systems

Establish quality coordinator's role in Engineering department: Responsible for GMP Compliance of engineering systems and services

Planning of pharmaceutical API-plants, waste air treatment, biopharmaceutical plant up to 20 MEUR

Chemieanlagenbau/Process Plant Engineering