Curriculum Vitae Dr. Gunther Roiss

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1 Curriculum Vitae Dr. Gunther Roiss Surname First name Place of residence Roiss Gunther Zurcherstrasse 11, CH-4332 Stein Date of birth Civil status Nationality Divorced, no children Austria Phone / Website gr@roiss.de What distinguishes me I have an analytical mind and can quickly familiarize myself with new problems and topics. My work ethic is trustworthiness and reliability in every aspect of my job. I love navigating through my work with ease, can distinguish essential things. I pay attention to all the details for a better overview. I ve maintained peace of mind at work by delivering careful results and successfully competing projects. I am never one to shy away from heavy workloads, I am flexible and have a high level of expertise and experience in leadership, production issues, quality issues, project leading, workshops, LEAN, 5S, CIP, TPM, Kata, CI, operational excellence, shop floor management, change management, automotive, manufacturing, GMP, medical technology and pharmaceuticals. My motivation is to deliver 100% of targeted work with the attention the work deserves. Professional background Ensure permanent audit readiness of a chemical laboratory A chemical laboratory had repeatedly been negatively conspicuous during audits. It was necessary to restore an audit-proof overall condition. This was done by visual shop floor management including planning management. Voice of the customer analysis, on-site problem analysis, setting up a change management process. Introduction of LEAN basic methods, introduction of a shop floor management system, introduction of visual baseline planning. Reprocessing of SOPs, training of employees in workshops and PowerPoint. GEMBA tours with the management and the customers. My flexibility allowed my expertise to train employees without any problems; the flexibility also helps my structured response to customer requests. The lab was praised in independently conducted audits and now serves as a best practice for positive change of management across the plant Interim laboratory manager Seite 1 von 5

2 In a chemical-physical laboratory with a focus on medical devices, laboratory work was carried out for several months on an interim basis. Management of approx. 10 employees, evaluation of analysis results, creation of SOPs, CAPA processing, evaluation of deviations, order management, budget control, outsourcing of analyses, security officer. The laboratory operation was successfully maintained until the appointment of a new laboratory manager Lead time reduction in a pharmaceutical-chemical laboratory under GMP conditions In a chemical laboratory in daytime operation with about 20 employees, who is responsible for the release tests of production, the lead time of the individual releases should be significantly reduced. Process analysis, organizational analysis, analysis of GMP-related steps, documentation analysis, SOP analysis and customer analysis. After the analysis phase; the project had to be divided into 2 projects, both of which ran for several months. Selection of personnel, support of personnel development, customer negotiations, redesign of SOPs, simplification of examinations, processing of CAPAs, simplification of documentation, development of uniform communication structure, development of structured time modules, creation of a shop floor management system including whiteboard, management of laboratories and training of laboratory managers. The lead time could be reduced by 8 days or 60% after the end of both projects Bottleneck management in a production plant of the pharmaceutical industry and production increase in the GMP area A packaging machine for pharmaceuticals had only 30% OEE availability and was thus the supply-limiting bottleneck in the entire plant network. Internal departmental measures remained ineffective. Training of employees, preparation of training documents, management and coordination of a 3-shift operation, technical weak point analysis and organizational weak point analysis. FMEA analyses, realistic objectives, action plan, monitoring of implementation in the GMP area and presentation of the results of the plant management. Resolve bottleneck, increase OEE availability to 70% Create and run a departmental training series For in-department on-boarding, a training plan and several training sessions required for the department should be prepared and executed. For this purpose, the knowledge that is available to the profession, such as inward and outward migration, proper clothing and production-specific knowledge, should be prepared in a didactic manner and communicated effectively. Analysis of the existing training concept. Preparing the SOPs in Seite 2 von 5

3 PowerPoint slides and in practical preliminary exercises. Set up various mock-ups for training purposes. Selection of several internal and external assistant coaches. Building a new training culture for employees and executives in production. Collaboration with the TWI Institute. Auditable documentation. The training concept has been successfully implemented and is still in operation today. Other departments have copied this on-boarding and training system because of its success Increasing the right-first-time rate in a pharmaceutical company under GMP conditions (Solida) In a Galenic mass production in 3-shift operation with a total of 120 employees (with high staff turnover), the error rate should be lowered and thus the Right-First-Time (RFT) rate should be increased. Analysis of the genome using fishbone, evaluation with Pareto and creation of a value stream. Simplification of the key figures. Make key figures transparent. Timely (daily) informing of key figures. Weekly problem discussion and retraining in small groups. Editing CAPAs, supervising batch releases, establishing a structured communication at the shop floor. Gradual integration of support and neighbouring areas such as maintenance and quality control. Training of basic elements in leadership behaviour with masters and foremen. The error rate was reduced by 90% within the 9 month project period. The right-first-time (RFT) rate increased by several 100% Reduction of a shift in the automotive environment (Sheffield, England) In a production plant with approximately 500 employees, savings should be made in order to remain marketable. For this, a 3-shift operation had to be reduced to a 2-shift operation with a constant output. Balancing project with classical project structure (time, capacity, and budget). The clock rates stored in the finance department were checked by an actual recording and the new financially required clock rates were set. After that, each clock cell was individually analysed, optimized and then re-clocked. Bottleneck processes were outsourced on a sideline. The supply logistics were completely separated and adapted. The conversion succeeded. The required savings could be implemented. The company is still in the market today Planning a factory for fuel cell drives with unknown sales figures For a German car manufacturer, the sales could not submit any figures for the sale of fuel cell vehicles. There were too many unknown factors in this new segment. Nevertheless, the board needed a finished planning of a factory if the demand should increase. Analysis of the different strategic customer and sales scenarios. For sales, it was impossible to realistically evaluate this new market segment. The factory, hall and production planners absolutely needed an estimated Seite 3 von 5

4 sales volume to be able to plan a new factory. Analysis of stakeholders and their interests. Structure of a decisionmaking body. Involvement of international experts. In numerous round tables a modular production method according to LEAN methods could be enforced. Study trips abroad to similar production methods (different products). Creating and presenting a whitepaper and building a modular production line as a mockup. The new planning concept attracted attention and approval across the Group. A module was realized as a mockup and presented to the management (board) Lean, 6 sigma and process manager Original 2-year Toyota LEAN training, partly on-site in Japan Understand the differences between LEAN in Japan and in Germany LEAN projects in the areas of production, logistics, planning Program development of multiple LEAN efficiency and stability projects including control and monitoring (used by suppliers). Experience with electric drives and fuel cells Production Manager Die Casting and Chill Casting Aluminium and mechanical processing Ensuring production (mass production) to the customer Management of approx. 350 employees Ensuring special parts (single part production) to the customer Quality engineer for safety parts Professional assurance of material testing in materials testing laboratory Leadership of 9 employees Academic Education Seite 4 von 5

5 Completion of Ph.D. Technical University Freiberg (Germany) Dr.-Ing. Materials technology for the synthesis and analysis of a new bioceramic material Completion of the diploma thesis Technical University Freiberg (Germany) Degree as Dipl.-Ing. for materials technology Completion of the diploma thesis (FH) University of Applied Sciences Jena (Germany) Degree as Dipl.-Ing. (FH) for materials technology Degree in chemistry Technical University of Vienna (Austria) Additional training 6-Sigma Black Belt, several in-depth training courses in LEAN management, change processes, project management and leadership Train the Trainer (Chamber of Commerce) GMP - Pharmaceutical Technician (Chamber of Commerce) TWI Job Instructions (TWI Institut) TWI Job Relations (TWI Institut) Languages German English Native language Fluent in English Computer skills MS Office Linux SAP Extensive knowledge, experience, understanding and skills in Word process, Excel and PowerPoint Extensive knowledge, experience and understanding of Linux software Average skills and experience on the usage of SAP Seite 5 von 5

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