Dr. Sébastien Fuchs

French subsidiary, sites of Chatenois (67), Lièpvre (98), Belleville (69) and Arcueil (94)

Performing audits of pharmaceutical groups suppliers, based on various quality standards (ISO 9001, ICH Q7 & IPEC)

Quality Management (systems & portfolio of pharma products). - Quality Assurance: change control, product quality review, risk analysis, validation, data integrity - Customer support: audits, quality agreements, documentation compliance, complaints - Product compliance: specifications management (Ph. Eur., USP-NF), labeling, CoA, CAPA Other key words: GMP (Excipient, IPEC, API, ICH), computerised systems (GAMP5), document management, suppliers, questionnaires, minitab, project manag., manager

Implementation, harmonisation & sustain of Good Manufacturing Practices as per IPEC and ICH guidances, in the cereal division (Syral) of the Tereos Group. Key words: change control, quality system, validation, SAP, pharma, risk assessment, project management

Lead process monitoring, troubleshooting and optimization (changes, validation) on an API multiprocess manufacturing plant. Continuous improvement projects on technical, quality and organizational processes. Member of the site leadership team. Other key words: FDA, ANSM/AFSSAPS inspections, Manager

Technical support for manufacturing activities from lab to pilot & industrial scale, under GMP (ICH) conditions. Development and Troubleshooting. Six Sigma & Lean projects (Black Belt). Other Key words: manager, deviations, incidents, root cause analysis, statistical process control, proactive process analysis, optimisation, change control, Trackwise

Applied research in organic chemistry. Multi-step / total synthesis.

PhD. Research on sensitizing chemicals. Organic synthesis.

Training period (4 months): organic synthesis at lab scale.

Research on sensitizing chemicals. Organic synthesis. Lab courses taught to undergraduates.