Das Team
Unser Team besteht ausschließlich aus qualifiziertem Personal, das zuverlässig und kompetent für Sie im Einsatz ist.
Our Team meets many years of Medical Device and GMP experience with Validation and Regulatory Affairs Solutions.
Originally starting for a toolmaker and injection moulding specialist he is regarded by his peers as a specialist in Medical Device and Pharmaceutical Process with excellent interpersonal skills and deep knowledge in Biotech and Fill-Finish. Strong skills in Regulatory Compliance, Quality Management, and Risk/Deviations Management complete his profile.
Supporting suppliers to achieve common goals: Costs and Target Control for Machine incl. Supplier correct
Engineering & Validation, Up-/Downstream & Fill & Finish
Capex, Revamping and Compliance
CAPA owner and Change management expert
WINCC / C++ / TIA / Siemens S7 / Beckhoff TwinCAT3, SPS Analyzer
Catia / Creo / ProE / SolidWorks / Moldflow / CAE / Vision Software Suite Control, ifm Vision Assistant.
ISO 14971:2019/EN ISO 14971:2019+A11:2021 and ISO/TR 24971 across all life cycles for your medical device
for product and process with different systems and Impact Assessment, Risk Assessment by means of FMEA and RiA, ETQ und Q-Ware Expert
Definition of Interfaces/Communication Paths (e.g. PI, Electronic
Batch Record), Network for Production Process Sequences and
Automation Engineering / WINCC / C++ / TIA / Siemens S7 / Beckhoff TwinCAT3, SPS Analyzer / Gamp 5 / CSV / Simatic PSC
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