Andreas Schmidt Email & Phone Number

Germany

Darmstadt, Hesse, Germany

Darmstadt, Germany

Heading QA and QC with 229 people. Accountable for Quality Systems and release of solids, sterile and non-sterile liquids (12000 batches, 485 Mio blisters, 30 Mio steril ampoules and 25 Mio non-steril units per year) for worldwide supply including U.S.A. Budget: 30 Mio Euro

Ingelheim, Germany

Heading a group of 135 people. Accountable for the quality system of three manufacturing sites in Germany. Responsible for the QA-systems CAPA, Deviations, Change Control, SOPs, Training, Inspections, Qualification and Validation. Successful U.S.-FDA Warning Letter remediation.

Heading a group of 54 people with the overall responsibility for all Quality Assurance and Regulatory Affairs topics for all Drug Substances/APIs manufactured at our Ingelheim site. Responsible for the final release and CMC-documentation of these Drug Substances to be placed on the market in about 70 countries for drug products and clinical studies support.

Heading a group of 35 people preparing, submitting and managing all authority and customer related questions with respect to Drug Regulatory Affairs in the Drugs Substance/API field of the CMC part of pharmaceutical registration dossiers worldwide.

New Business Development in the pharmaceutical industry. Acquisition and Project Management of New Chemical Entity and Drugs Substance projects from industrial customers in U.S.A., U.K., Ireland, Germany, Sweden, France, Switzerland, Japan and Australia. Strategic Business Development in Japan.

Responsible for the continuesly cGMP-compliant production of 45 drug substances in a three-shif-system, including 400 intermediates. Head of 50 employees working in assets of 60 Mio. Euro with a production plant budget of 18 Mio. Euro. Producing controlled substances according the applicable german act.

Responsible Plant Manager Alkaloide, producing cGMP-compliant drug substances resulting from herbal sources. Head of 25 employees.

Responsible for the logistic team of drug substance production plants with three employees. Acting plant manager of these drug substance production plants.

Responsible for the optimization of current chemical production processes, transfer from Process Development to Production Plants and process validation according cGMP with two employees. Project Manager for a laboratory reconstruction project. Acting Head of the analytical In-Process-Control laboratory located in production.

Responsible for international registration documentation for drug substances (U.S. Drug Master Files, european Drug Master Files, Certificats of European Pharmacopeia, Manufacturing Descriptions for CMC-sections of pharmaceutical dossiers). Responsible for registrations according european chemical control regulation acts and performing audits according ISO.

Systemic Leadership, Curriculum

Auditor, Total Quality Management

Certified Total Quality Management Auditor according DIN EN IS 10011-Part 2. Certified by the Notified Body EQ ZERT (TGA-ZP-15-93-80)

Qm Specialist, Quality Management

Six months training at the consulting company item communication, Aschaffenburg, Germany. Training contents: auditing, quality tools in.

Phd, Chemistry

Activities and Societies: Cooperation with the Preclincal Research Department of the pharmaceutical Devision of E. Merck, Darmstadt.

Diploma, Engineering Science

Activities and Societies: Member of GdCh (Gesellschaft deutscher Chemiker)Study of Chemistry with a focus on Engineering Science resulting.

University Entry Degree