Michael Goldmann

• End-to-end process know how on manufacturing of pharmaceutical products • Vertical and horizontal integration and process reengineering (process optimization and harmonization, quality, efficiency improvements, strategy, economy, technical and regulatory requirements) • Understanding of recipe based automation accordingly to batch manufacturing industry standards (ISA S88 & S95) • Knowledge of GxP requirements and qualification of computerized systems

• Maintained Operations and the validated state of the global computerized system for managing drug safety and pharmacovigilance. • Planning, design and specification for the migration of the global computerized system for managing drug safety and pharmacovigilance. • Planning and design of a project for implementing an electronic Trial Master File.

• Maintained operations and the validated state of the global clinical systems (Cinical Trial Management System, SharePoint collaboration plattform, electronic Trial Master File). • Consultancy and trainings for internal and external users. • Definition and implementation of requirements. • Development, implementation and optimization of quality standards for systems and processes.

• Project Lead for implementing a computerized system for fleet management. • Optimization of business processes increasing efficiency. • Cross-departmental collaboration. • Presentations to and justification against internal / external stakeholders.

Computer Science, Business Informatics and Economics Management of IT projects Collaboration Business Process Design

• Trainee in various roles and in various departments internal and external • Project SME Database: Implementing a web based application for Mobile Maintenance • Siemens LLC United Arabic Emirates: Project Lead for implementing an ERP interface for digitalization of paper based incoming invoices