• Process risk analysis and validation master plans for a complex manufacturing facility for combination products.
• Project management for phase 1 of the relocation of sterile microbiological lab facilities.
• Support in risk management and clinical evaluation of an in-vitro diagnostic for certification under the oncoming IVDR (In-vitro-Diagnostics Regulation).
• Support in the restructuring of the R&D Quality unit of an international medical device manufacturer.
• Medical device seminars and webinars, especially US-regulations, design controls, CAPA and complaint management. 
• Various GMP-compliance audits (finished dosage forms, packaging materials, APIs) in European countries.

• Project management services for Technical Due Diligences at various pharmaceutical and medical device production sites abroad (contract with a European investment group); services included GMP compliance status analyses and assessment, cost situation and prognosis, organization, key personnel, future utilization scenarios
• GMP training in Germany and abroad (pharmaceutical and medical device manufacturers).
• Project management for process optimization in an API production facility in Spain.  Reduction of operating costs according to preset aims. Implementation of performance specifications.
• Business process optimization and GMP compliance consulting for a biotech manufacturer of pharmaceutical products (project management, GMP gap analyses, cost analyses, improvement of internal operations).
• Support and assistance services for a Bulgarian drug manufacturer during the generation and implementation of a GMP compliant QA system, a cleaning concept and plant qualification.
• Preparation of a cold chain transport qualification concept for a German manufacturer of medicinal drugs (general qualification plan, specific plan for performance qualification of individual drug transports).
• GMP compliance analyses, benchmarking study, in-house training, preparation of facility modification concepts for pharmaceutical manufacturing companies.

• Preparation of a German manufacturer of pharmaceutical products for the FDA Pre-Approval- Inspection. Project Management of various activities, e.g. preparation and revision of SOPs (QC, procurement, warehousing, hygiene, labeling), approval compliance check (analytical methods, production processes, manufacturer.
• GMP compliant development of processes for the handling of deviations and out-of- specification results in a pharmaceutical production facility. Preparation of relevant SOPs. GMP risk analysis of individual process steps in the production of parenterals.
• Revision, assessment, and re-organization of procurement processes in a pharmaceutical production facility. Preparation of procurement organization for a planned major investment. Development of a procurement manual including descriptions of all processes and responsibilities.
• Coordination of all qualification and validation measures in the development of a pharmaceuticals distribution system in Germany for one of the leading logistics companies. Qualification and validation of cold storage warehouses and transportation that guarantees maintenance of the cold chain.
• Project management: feasibility study for the partial relocation of a pharmaceutical production facility. Definition of required technical and organizational measures, cost estimates and research of the impacts on manufacturer costs.
• Project management: Development of logistic processes as well as qualification / validation for a Turkish pharmaceutical production company (new construction project).
• Audits of API, packaging materials, medical device, and pharmaceutical manufacturers (EU, Turkey, USA).

• Fresenius Kabi Sweden: Organization of a strategic procurement department; implementation of GMP/QM compliant processes, development of SOPs and preparation of a procurement manual for SAP R/3 and SAP-BBP.
• GMP and business audits of suppliers (Sweden, Denmark, Ireland, Germany, Switzerland)
• Introduction of SAP-BBP (business-to-business-procurement) for the Swedish organization (1.100 employees). Requirements analysis, calculation of cost effectiveness, development of catalogues.
• For capacity increase and start-up of Fresenius Kabi-owned facilities for the production of triple chamber parenteral nutrition bags; strategy for production cost reduction and simultaneous ramp-up for a third party manufacturer in Ireland.
• Economic and organizational analysis of a large scale project (new infusion solution manufacturing plant in Uppsala; Pharmacia & Upjohn) prior to acquisition by Fresenius. Re- organization, planning and budgeting of project continuation by Fresenius.

• Business development: pharmaceutical sector, international production plan, head of material management, production planning and controlling for the production of infusion solutions.
• Project management: cost effectiveness calculation, investment request and basic engineering for a large scale project (new facility for infusion solutions in Friedberg/Germany). Deputy project manager during the detail engineering phase.
• Project management: guarantee of product availability during the relocation of infusion solution production from Bad Homburg to Friedberg and Graz. Transfer of required product documentation for over 6,000 items (production and approval documentation).
• Subproject management: business process optimization for Fresenius AG. Survey and assessment of 600 jobs / positions and re-organization according to associated business processes.
• Project management: Generation of a European production concept for infusion solutions after the purchase of four production facilities by Fresenius AG. Objectives: Reduction of overall production costs, adaptation of capacities to requirements and demands. Comparison of production costs in European production facilities. Development of measures for production cost reduction at the Bad Homburg facility.
• Project management: Introduction of modified packing materials in order to reduce material costs for various infusion solution products. Cooperation with QC, approval and production.
• Project management: Reduction of costs for printed packing materials through the optimization of ordering processes (in co-operation with the supplier). Corresponding supplier audits for evaluation of existing and new suppliers.

• Projects in the manufacturing and construction industries containing: strategic orientation, cost reduction programs, analysis of value chains, site comparisons. Most of these projects were executed in Germany.

• Projecting and sale of fermentation plants for the pharmaceutical industry.  Projects in Europe and the USA.

• Doctoral thesis on the scale-up of airlift bioreactors to production size, optimization of process parameters in (baker's) yeast fermentation, project engineer for facility start-ups.

• Continuous GMP-education for both pharma and medical device manudfacturing
• Project management-expert (RKW/GPM), diplomaJuly 2001
• Co-author of „SOPs for GMP areas (SOPs im GMP-Bereich)" published by „Bundesverband der Arzneimittelindustrie (German Medicines Manufacturer’s Association), Bonn, Germany
• Frequent in-house trainer for pre- FDA inspection trainings

German | Native

English | Business fluent

Swedish | Business fluent

Spanish | Good

French | Basic

Italian | Basic