Dr. Lambert Michael Email & Phone Number

Worldwide Supplier Qualification (API, FDF, Logistics, External Contractors) including Auditing, Paper Evaluations, Due Diligence, Risk Assessments, etc.Managing of corporate Self Inspection Program.Qualified Person and Information Officer in accordance with German Drug Law (AMG).Deputy of Senior Director Corporate QM Department.

GMP surveillance responsible for Europe incl. - GMP Audits for API-, FDF- and Contract Manufacturers, - corporate self inspections, - customer, certification and authority inspections- international project management regarding QM and GMP topicsDeviation and complaint management, CAPA and Change Control.Continous improvement of global corporate quality.

Planning and installation of a R&D lab and a biotechnological large scale upstream/fermentation plant (both risk levels S2/L2) for highly active pharmaceutical ingredients (hAPIs) according GMP standards within the Business Unit Pharmaceutical Ingredients at Chemicals Division of Heraeus Precious metals GmbH & Co. KG.Manufacturing of hAPIs for chemotherapy.

Installation of a R&D lab and a production/fermentation plant (both risk level S1/L2) for Bioreagents within the product sector Rapid Tests of Macherey-Nagel.Development and production of:- toxicity tests (e. g. luminous bacteria test, nitrification inhibition test)- photometric rapid tests (e. g. BOD5, pesticides, ethanol, methanol, TTC/sludge activity).

Doctorate, Biotechnology

Diploma, Biology

A Levels (German: Abitur), Main Subjects: Biology, Mathematics