Referenzen

  • Experienced consultant in the quality assurance and management, regulatory affairs areas, extensive knowledge and understanding of the Medical Devices, Bio- and Pharmaceutical, Medical Devices and Healthcare industries.
     

  • Supported and led as Interim Head of Audit Management the Inspection Management with following activities: prepared the needed documents and ensured compliance, trained internal staff (practice), verified process flows and ensured compliance with regulatory affairs and the current quality guidelines.
     

  • Preliminary monitoring of the Laboratories and Production section (R&D and Quality Controls), as well as of the internal staff for GxP Audits and FDA Inspections. Acted as a project manager in the pre-approval inspection stage for Biopharmaceutical APIs – Biosimilars. 
     

  • Led the production site from Brandenburg to Berlin for a medical implants manufacturer and held responsibility of several processes: relocation and validation master plan, support in the construction phase of the production area, led the qualification of the new production area and clean rooms as per GMP guidelines, moved production of medical devices and requalification of equipment and validation of manufacturing process according to GM guidelines.
     

  • Upgraded the Quality Assurance Systems from ISO to GMP standards within 3 internal departments of the medical devices company: production, engineering and quality departments. Managed the Certification process from Notified Body as per the ISO 13485 regulation.

 

Biopharmaceutical /Vaccines industry
 QA SME and project management on production sites :

  • cross functional activities between Quality - Tech Ops – QC

  • preliminary of GMP System Audits: FDA and other authorities

  • Interim Position Head of Audit management in the QA System Interim Q – Single Point of Contact from CMO to client

  • Quality Management for wholesale license·  
    prepared and submitted the Q – System for a new wholesale license of an European company in Germany and successfully release without any observation

  • Project management DS/DP/MD

    Site changes and/or new constructions of whole productions with responsibility for the processes

    Generation and realization of requirements incl. all processes and documents from technical (Building and GXP equipment) and scientific (aseptic, GMP) steering relevant for quality management and performance of projects for submission to international agencies 

  • Covered the Regulatory Affairs, R&D and Quality Assurance within manufacturing department of a global ophthalmological healthcare products manufacturer. Prepared the Chemistry, Manufacturing & Controls (CMC) documentation including expert report. The responsibility included all life cycle regulation processes worldwide (approx. 49 countries) for medicinal products, cosmetics, medical devices as well as nutritionals.