Ralph Gross

General Manager Hörschelmann Information Technology Consulting Service Co., Ltd. 06/2022- present Arbitrator HIAC- Hainan International Arbitration Court - Arbitration - Mediation - Business Consulting Hainan Free Trade Zone Business Development - Support China businesses to go INTERNATIONAL (capital investments) - Technical Support of Pharma and Food Businesses - Technology Transfers - Validation/ Qualification/ Certification (CE; TÜV; EMA; FDA) - FAT's and SAT's - Trainings - Business Consulting Hainan Tourism Promotion for Haikou Government - promotion of tourism and sport in social media - promotion videos and press support Technical Director Romaco Group Romaco Customer and Shared Service Center 08/2020- 05/2022 - Coordination of all Service-Activities and technical support between Romaco China and Romaco Group (in charge of 5 EU-based factories) - Implementation of QA- and Service-Department and related standards - Leading the Trial Laboratory R-CNSPC (Romaco China Solid Process Center) - Leading the Shared Service Center China including all Romaco Group products - Supervising the Qualification (FATs and SATs) of all Romaco Group products - International Sales Support for TRUKING pharmaceutical production lines Senior Business Consultant; China GEA Lyophil GmbH Hürth, Germany QA Department 07/2013-10/2018 - Coordination of all business activities between GEA-Hürth and GEA-Beijng and Shijiazhuang/ China with focus on QA-aspects - Implementation and supervision of QA-standards for SLTM (SMART LYO)-freeze dryers production (creating of assembly- and test- SOP's) - Accompanying the production relocation from Beijing to Shijiazhuang - Establishing the production- and comissioning processes for freeze dryers at the new factory in Shijiazhuang - Realization of the first SLTM-projects in Shijiazhuang - Maintaining of CAPA/ CLOG (Corrective and Preventive Actions/ Claim and Observation Log) - Qualification of SLTM-freeze dryers and ALUSTM (Automatic Loading and Unloading Systems) - Factory Acceptance Tests (FAT)-finalization and certification with international customers - Site Acceptance Tests (SAT)- finalization and certification with customers in China - Creation and execution of employee trainings in China Product Manager VHPTM Systems/ VAPOVAC™ GEA Lyophil GmbH Hürth, Germany Sales/ PIM (Product and Innovation Management) Department 02/2009-06/2013 - Presentation of VAPOVAC™ technology worldwide - Retrofit Evaluations for VAPOVACTM to competitors Freeze Dryers - Maintain quotation basis for sales - Case study: Comparison between VHPTM-DV (deep vacuum) and VHPTM (atmospheric) technology - Process optimization for fast VHPTM-DV performance - VHPTM-cycle development and optimization; validation support - Established validation standards for VAPOVAC™-technology (Validation Cross, D-Value, LSKM) - Active sales and promotion of VAPOVAC™ technology worldwide Product Manager VHPTM Systems Steris GmbH Hürth, Germany Electrical Engineering Department 04/1995-01/2009 Overall Responsibility for VHP-Applications especially the VHPTM-DV-Sterilizers for Freeze Dryers - Established quotation basis for sales - Customer training - Evaluation of Freeze Dryers worldwide - Adaptation of VHPTM-Technology to Freeze Dryers (mechanical-, electrical-design, programming of interfaces, ISO9000 documentation) - Commissioning of the systems - Preparation and Conduction of CE-approvals of DVTM30, M1000STM (Steris-US VHPTM generator products) - Introduction of redesigned M1000STM-Generators to Market-Leaders like BOSCH Service Manager AMSCO Deutschland GmbH Mannheim, Germany Service Department 09/1993-03/1995