Germany
• Transformation Leader ( SMS 2.0 QC Ecosystem @Riells, 2024) • Transformation Leader ( Q Booster @Campinas, 2023) • Co-Booster Leader (Q booster @LLB, 2022-2023) • Change Leader (Q booster @Riells, 2022) • I-DCM Deployment • Focal point @ Quality Related and digitalization Projects (DGBI,InQ, Minor Deviation Management, Qualipso, Quest etc.) • Responsible of Site SMS KPIs (PCT, Q Productivity, etc.) • Contributor for Lean Program and Lean Projects • Moderation shopfloor related projects (i.e: performance & lean activities, VSM, +QDCI and other projects) • Take active role for preparing and updating Key Performance Indicators. • Deploy lean activities with local and global sites. • Take active role for creating lean culture and deployment • Contribute developing and using lean methods and in site. • Prepare Lean and SMS related training with align SMS Academy and give of them. • Take active role on Continuous Improvement Projects and Provides timely closure of these projects. • Contribute to the development of SMS, +QDCI, Kaizen and 5S team members, guide them. • Support to other industrial projects. • Coordinates site suggestion system. • Gemba Problem Solving
• Lead the team mainly for below topics: - Manager of Deviation Management & Customer Complaint - Gemba walks (Production & Packaging, Quality Control) - Manager of Product Quality Review - Release and annihilation operation - Recall management • Qualified Person of sterile liquid- non-sterile liquid, pomade, and beta-lactam products (Production & Packaging & Quality Control) • SMS focal point at QA department • Leader of Change Control Management • Contributor to the Risk Management • Leader of Audit Management (Customer, Authority, Internal, Supplier) and • Lead Auditor of Sanofi. • Internal GMP Trainer • Focal Point of Human Error Management System • Lead the projects Manufacturing & Quality in Site - • Implementation (Deviation Board, Comet, Material Management, Turquoise Project etc.)
Quality Systems I mainly deal with the following topics; - Internal Audits (Planing, realization,performing as lead auditor, reporting) - On site Inspection - Supplier Audits (Planing, realization,performing as lead auditor, reporting) - I’m one of the global lead auditor with experianced API, excipient, packaging material and finished product suppliers of Zentiva and Sanofi. - Authority and Customer Audits ( Preparation before tha audit, participation as supervisor, Capa Plan Preparation & Follow-up) - Risk Management (Participation in risk management studies in Zantiva Health Products) - Deviation Management - Change Control Management