Services Portfolio of some realised projects (click “+” to expand)
- Rationalised Werum PAS-X project with Quality Management; detailed the scope and requirements, integrated Kanban, RACI, baselined Project & Resource Plan, Change Management & Validation Plan. >30 stakeholders locally.
- Reverted “Agile” to waterfall methodology with demo’s and phased go-live. Business Analysis go-live options.
- GxP Business Analysis on Functional Requirements and Cost/Benefit-Analysis for phased roll-out.
- Business Analysis for Rockwell Pharma Suite & SAP EWM integration. Responsible for FS approval.
- Business Analysis for Integration Pharma Suite and legacy Propack Paletti warehousing, responsible for Techno-Functional architecture, Storage Area’s / Storage Locations optimization, 1st site Proof of Concept.
- MES Business Analyst on Emerson Syncade solution for a pilot at two primary and secondary manufacturing sites. Accountable for MES solution conceptualization, FMEA, and functional proof-of-concept.
- Optimised MES/CSV double-waterfall validation approach and modular deployment-testing, focusing on Software Lifecycle Management and project risks. Co-operated closely with corporate MES/QM. 6 team members.
- Started as CSV lead for greenfield site / commercial production license. Co-operated closely with QM, Programme Manager, 4 Project Leads, with Siemens, QP, solution architects and test teams.
- Changed from “big bang” waterfall to hybrid agile with waterfall-modules; HLRA, VP, fFMEA, 21CFR11 re-assessment, data integrity, test strategy DQ-IQ-OQ-PQ, Traceability Matrix, Incident & Defect Management.
- Succesfull go-live & passed the EMA inspection without any finding.
- Project conceptualisation & definition for a 2M Process Information Management Solution (part of 15B project).
- Business Justification, Planning, Project Risk Management.
- Business Analysis, MES maturity studies, Management Consultancy.
- Hosted an Industry 4.0 conference workshop.
- MES/MOM sales at executive level.
