Serialization - Track and Trace Consultant / Project Manager
Since October 2016
Delivering as freelancer:
- The full project management of Track & Trace projects from kick-off to closeout.
- Consultancy and assistance around serialization regulation and implementation into the customers packaging process and supply chain.
My current skill set:
- Understanding the integration challenges coming with Track & Trace projects from Level 1 to 4, on new packaging machines or retrofitting older machinery.
- Understands the full implementation and validation side of T&T deployments in the pharma (GAMP5)
- Able to coordinate and delivering serialization interfaces between software components and serial number management platform.
- Ability to drive completion of activities among diverse internal & external stakeholders.
- Deep functional and technical knowledge of serialisation landscape and requirements.
- EPCIS standards and SAP OER/ Aii /Advanced Track and Trace exposure.
- Network understanding (firewall, WAN, LAN etc.).
Senior Project Manager (PM)
Since July 2007
- 9+ years of delivering Serialization (Track & Trace) projects with multiple OEM’s for customers all over the globe and now mainly focusing on EMEA.
- Managed +70 large, critical Projects for major and mid-tier Pharmaceutical (Merck 45x, Astra Zeneca 11x, Baxter 7x, Pfizer 1x, Amgen 4x, Sharp 1x) and Agro customers (Bayer Crop Sience 3x, Syngenta 4x).
- Deployed and coordinated projects with multinational team members (Project Managers, Project Engineers and Field Engineers) and multi vendors and OEM’s (IMA, Marchesini, Pester,…).
- Last year coordinated a full production line with multi vendors (turnkey solution for China Animal Health Regulation) of +-2M USD. for MSD Animal Health (vendors: Neri, Etipack, Inno4Life, Domino, Videojet).
- Have a deep understanding of the integration challenges coming with Track & Trace projects from Level 1 to 4.
- Understands the full implementation and validation side of T&T deployments in the pharma (have in the past been creating validation documents following formulated methodology of the GAMP rules for full production lines – GAMP V model: URS-FS-DS, IQ-OQ-PQ).
- Express good client skills and performs regular onsite delivery assurance exercises to guarantee project execution in time, scope and budget.
- Technical Sales (in and external). Last year’s I’m actively involved in the quote process, set-up architecture and review of quotes and active quote negotiations with the customers.
August 2000 --- June 2007
- 7 Years of experience in coordinating full vision projects for customers all over the globe.
- Project manager for integration of vision projects in the pharmaceutical industry with all major OEMs and pharmaceutical companies.
- Deployed, engineered and coordinated +400 vision projects successfully with most major pharmaceutical companies.
- Technical Sales (in and external)
October 1994 --- August 2000
- 4 Years of experience in engineering, validation and integration of vision systems in the pharmaceutical industry.
- Engineering, validation and integration of vision projects in the pharmaceutical industry.
- Collaborated with QA department to create validation documents and formulated methodology according the GAMP rules for full production lines.
- 2 Years of experience in machinery engineering & design (electrical and mechanical design via AutoCad and Eplan) for Petrochemical and Industrial steelmaking industry.