Alexander Maurer

Functional Management System Owner: - Discrepancy Management - CAPA Management - Change Control - Investigation Management Leading global cross-functional GxP Compöiance Community

Divisional Management System Owner Data Integrity (DI), Computerized SystemValidation (CSV) & Good Documentation Practice (GDocP) - Leading divisional network of local SMEs - Member of global expert groups & task forces - Authoring SOPs - Supporting local units in Audits & inspections preparation and responses - Driving cultural change - Divisional Business Process Owner Long-term storage and archiving - Quality Culture Lead

Compliance Manager for comuterised Systems. Validation Support. Vendor audit support. Conducting Trainings.

Global Validation Manager for the Manufacruring Execution System (MES) PAS|X including: - Creation and Management of validation documents - Creation and Execution of Test cases (OQ/PQ) - Defending the system(s) in audits & inspections (e.g. FDA cGMP) - Data Integrity ...

Development of Embedded Software for medical equipment (rehabilitation) under Linux using Qt. Development of PC-based tools

- Business Leadership of the internal Track & Trace / SCADA Support team - Complaint Management - Track & Trace / SCADA Project Support - Building up 24/7 support - Support for project teams

- Implementation of complex international Automation Projects (Serialization) - Development of Serialization (Track&Trace) Systems for customers belonging to the Pharma Industry - Creation of functional specifications and design documents - Validation support - Planning and execution of project workshops - IT & Database administration - Implementation of Pre-FAT, FAT and SAT workshops together with the customer - On-site integration into ERP/MES systems - Server and Database setup - Commissioning at custome

• Leading of various Software Projects with international Development teams from China, India, Switzerland and the US • Creation of Technical Specifications • Software Test and validation • Task definition • Coordination • Training of Employees

• Leading an international Software development team • Creation of Technical Specifications and test plans • Task definition, Coordination and Training of Employees • Software coding • Design and implementation of complex Software Test and validation plans

• Responsible for the technical extension of the existing Product Portfolio • Internal Project Leading • Implementation of customer specific projects • Implementation of internal and external training • Improvement of the internal Development process (CMMI)

• Embedded Software Development (C/C++) for Industrial weighing devices • First experiences as Project leader • First Experiences with international product launch • Experience in the coordination of external Software Projects • Knowledgi in Process Optimizations (CMMI)

Studium der Technischen Informatik an der FH Albstadt-Sigmaringen mit Schwerpunkt Software-/Medientechnik. Diplomarbeit bei der Firma Mettler-Toledo (Albstadt) GmbH.