Bertrand - Agile coach pour la conformité

FREE LANCE CONSULTANT

• Hired to improve changes to configurations and set-up of IT infrastructure treated as projects delivered by Fujitsu after Global Delivery Center (GDC) based in Russia was closed and replaced by GDC in India.
• Used HBR case study “Strike in Space” as a transitional object to extract managers from their context and tensions and devise a course of action improving project execution.

• Review translation into German of training material (slides, computer-based simulations) intended for around 12 user roles held by end users of an Azure Cloud SAP PLM RD (Recipe Development) and SAP S/4 HANA (MDM, EH&S, QM, MM, PP/DS) to realize Insight-to-Launch (I2L) as well as Product Safety and Stewardship (PSS) end-to-end processes of the 1ADM project to innovate in the solutions work stream. Terms of reference include BPMN analysis, ADKAR, computer-based training, work guides and learning aids.
• Performed non-scripted tests on quality instance and isolated a number of problems ranging from missing value assignments types in specifications to ABAP errors, as well as dysfunctional rules to classify substances according to GHS.

• QMS and Compliance consultant to the VP global QMS and Compliance
o reinforcing hypercare and developing a change process for Quality Connect, the EtQ Reliance QMS deployed globally on the Cloud based on harmonized processes (Audit, CAPA, Change control, Complaint Management, OOS, quality events, risk management and supply chain audits) with Interfaces with SAP and with R&D applications
o contributing to conversations preparing compliance to FDA requirements for Computer Software Assurance and for IDMP ISO standards.

• GLM multi-Project manager - team of Capgemini developers in India - Agile project method using CATS to track usage of time and Sopheon Accolade for portfolio management.
o Extension of Global Label Management (GLM) usage to deliver GHS product labels and dangerous goods transport labels for waste and for China on behalf of a plant manufacturing super-acids in France (REACH and CLP). Project finished.
o Start GLM+ usage for a plant manufacturing surfactants in Netherlands (REACH and CLP). GLM+ used by toller drumming and warehousing for Solvay. Remote connection of toller + laboratory sample labels (raw material, production, sample library) + test-based data quality improvement. Project finished.
o Extension of GLM usage to print client-specific labels for vanillin products manufactured in France (REACH and CLP), USA (GHS US) and China (GHS China). Addition of language for EHS phrases + harmonization of label texts along geographies + deprecation of Excel-based spreadsheets + process integration with Salesforce-based process to collect and authorize client requirements. Project finished.
o GHS, transport and customer labeling for a plant in Germany (REACH and CLP) mixing specialty chemicals for applications in the automotive industry. Sub-project or a broader project to digitize the shop floor. Seven new generation variants of labels including four GHS labels undergoing Computerized System Validation. Data matrix compliant to GS1 standards prints on all labels. China labels fulfill General Administration of Customs of China (GAC) requirements for single window declaration system.
• Collaboration with CGI engineers to develop on Silica generic label a proper choice of language and to fix many non-compliances hampering the usability of labels in French, Italian, Polish, US, Korean and Chinese plants. Test-based iterative improvement of label templates but also of EHS properties, of DTM parameters and of EHS phrases.
• Lead tester for GLM+ in the AERO project done to comply to ITAR (International Treaty on Arms Regulation) in the Composite Materials GBU. Responsible to deliver to German plant on-site support at cut-over time in the global roll-out spanning 5 US sites, 2 UK sites, 1 China site and 1

PROJECT MANAGEMENT CONFIDENTIAL

• Project manager - team of 7 people
• Fine tuning of new business process to handle globally (DE, AT, PL, US, CN) the use of dangerous substances within all manufacturing processes by usage of and alignment on SAP EHS on HANA S/4
• Mapping of functionality of a to-be-replaced Lotus Notes point solution (used in one of the two LoB to handle and label 2000 materials containing dangerous substances) with SAP EHS including GLM
• Identification of relationships within SAP data needed to enable chemical exposure profiling of workers.

DIGITAL SERVICES

• Have provided technical assistance to build terminographic content valuable to the construction industry with special emphasis on technical norms and on high risk activities such as asbestos removal.

• Program manager for SaaS-delivered tech platform with projects to grow infrastructure, to design application, to crunch regulatory texts and to deliver regulatory intelligence. Technologies Angular and MongoDB.

DIGITAL SERVICES

• Assisted founders to learn from minimal viable product and to change scope, technology and provisioning of data so as to reach go to market
• Project manager and database designer (from conceptual to physical) of an implementation of terminographic processes and application software (design – build- load test) yielding digital services delivered as SaaS for compliance to EH&S and Customs regulation as well as to life science best practices (ICH, HL7, EMA, IDMP) in 6 languages. Technologies Sencha Touch, MySQL and Corticon.

FREE LANCE CONSULTANT