Peter Berger

Background

About Peter Berger

Medical Device Regulatory Affairs - Software Validation & Computerized system validation - Auditing: Quality Systems - Manufacturing process validation - Data Integrity Strategic and operative responsibilities to establish and optimize processes of a Quality Management System. This includes IT- compliance and IT risk management on a corporate level. Ottobock- Processes design and optimization Quality System related Raiffeisen- Process Management - IT Complicane and COBIT Pfizer: Leading and guiding point of contact and project manager for regional and global IT systems implementations from IT compliance perspective including GxP (GAMP) computerized system validation. International project support by guiding and leading virtual teams across Europe, CEE, AfME in close cooperation with management in the USA. My Management Experience: • Process and Quality Systems • Development of vision and strategy to implement Quality Systems and related processes • Support IT vendor audits in Europe • Leading project manager from quality and compliance perspective for regional and global software implementations • Close alignment with senior management and feedback to optimize Pfizer IT quality procedures • Operative realization of strategies to establish BT Compliance across CEE and AfME • Lead and develop multicultural (virtual) IT teams • Foster awareness and implement training programs • Conduct (creative) workshop as moderator and trainer • Implement and encourage Change Management procedures for IT applications