GMP Audits, Vorbereitung auf Behördenaudits , Mängelbriefbearbeitung, Consulting, Schulung

of early phase clinical studies. This included the oversight for 7 lab units involved in
preparation of toxicological studies and development of a stable and compliant
parenteral solution. Selection and qualification of external production sites for
production of clinical samples

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1993-2001 Plant Manager of the Penicillin Plant in Leverkusen for aseptically powder filling and
from 1995 onwards Plant Manager for the Parenteral Production Site in Leverkusen
for aseptically and final sterilisable filled vials and ampoules. During this time
responsible for significant restructuring activities for optimisation of the processes.
Establishing a new line for production of flexible non-PVC containers especially to
fulfill the requirements of the US market.

In this function responsible for the production and release of Finished Products and
APIs produced at Toll manufactures. This included selection of suitable Toll
Manufacturer and subsequent transfer activities. For routine production I was
responsible for the oversight about the production and quality control activities
including support for trouble shooting as needed. Performance of routine and for
cause GMP compliance audits at the Toll Manufacturers.

Further aspects were the validation activities for Bayer's products, the evaluation of
the Product Quality Reviews and were needed the improvement of the processes
and analytical methods.

As member of the Technical Auditing Group at Bayer I performed more than 100
GMP and GDP Audits as Lead Auditor for all pharmaceutical divisions of Bayer. I
reviewed several Bayer internal Global SOPs and supported the closing of
observations during authority inspections at our Toll Manufactures or at Bayer's
production sites.