Ghent Metropolitan Area
Ethical Perseverant Continuous improvement Innovation (technical and way-of-working)
Final responsibility for the following domains * Quality Assurance * Regulatory Affairs * GMP Compliance for the following sites * Belgium - Wetteren * Belgium - Balen * Belgium - Louvain-La-Neuve * India- Visakhatpanam and the following businesses * Pharmaceutical Fine Chemicals (drug substances / APIs and intermediates) * Amino Acids (APIs & intermediate drug product) * Natural Specialities (pharma, food, feed, cosmetic,...) * Agro/Tensiofix (surfactants and bii-stimulants for agro industry) Major improvement projects * guidance for the actual start-up of the API manufacturing site in India (Visakhaptnam) * guidance for the divestment of part of the activities of the Louvain-La-Neuve site
Responsible for the Quality Management System of the 3 sites of Ajinomoto OmniChem in Belgium (Wetteren, Balen, Louvain-La-Neuve) Major improvement projects * setting-up a new Quality Management System and preparing AminoScience Division for successful ISO9001 certification * implementation of a new ERP package (SAP, including Quality Module) * implementation of Sharepoint for managing quality related business processes * guidance and support to all authority inspections (US-FDA, BE-FAMHP,...) on all 3 Belgian sites * design a new Global Management System Guidance for the green field joint venture in India (Vizag), namely Granules OmniChem
Full quality management of Ajinomoto OmniChem's Balen site, while changing its activities to become a CMO (custom manufacturing organisation) active in manufacturing APIs (active pharmaceutical) Preparation of Balen site for its first (and several following) successful authority inspections, such at UK-MHRA, US-FDA, BE-FAMHP Successfully upgraded the ISO9001 certified Quality Management System of Balen's second business unit, namely manufacture of surfactants for the agro industry