Evaluation of existing production processes and deduction of conclusions regarding compliance and options of process optimization and increase in process reliability
Expert support of procurement processes, incl. drafting and matching of requirement and functional specifications, evaluation and selection of suppliers, project surveillance at the supplier, FAT, injection, installation, Commissioning up to SAT
Qualification of plants / validation of processes incl. periphery (TGA, logistics)
temporary projekt management (Change, CAPA)
Technology research, evaluation and implementation in existing production processes
Cardboard engineering for work place design and process optimization
Development of technology and methods
Analyses of product and process risks (FMEA) incl. Periphery (TGA, logistics)
Management of contact to authorities (for example BImschG, waste disposal)
Moderation of workshops on the issue of QM and risk elimination
Research, evaluation and implementation of second sources
Egulatory and technological supplier qualification
Patent research and assistance of patent applications
Audit preparation and follow-up, conduct of preventive mock-audits
Special Skills:
Packaging systems and plants according to DIN ISO 11607-1 and -2
Facilities for purest water production (production, storage and distribution)
Packaging processes (primary and secondary packages) in particular for sterile packaging according to DIN ISO 11607-1 and -2
Application of collaborating robots in the production process (in particular assembly and packaging)