Case Study
Tuesday, September 26
09:15 AM - 09:45 AM
Live in Berlin
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Our Site recently was divested to Delpharm and act as DCMO (Drug developer and Contract manufacturer) since November 2021. With its plants network, Delpharm is in the Top 5 CDMOs Worldwide. Transition was challenging for Site as
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Currently as Lead Serialisation Expert as Delpharm Poznan responsible for all serialization. In Delpharm so far managed to implement new site serialization solution (L3 system) after site was divested and left GSK network and also responsible for new serialization market implementation like China, Brazil, Bahrain, Turkey, Argentina, Indonesia, Kazakhstan, Uzbekistan and Hong Kong.
Before working for GSK responsible for
• Serialisation Project Coordinator
o Management of all serialisation aspects at GMS Poznan.
o Business Processes (gap analysis, LSOP, new markets (China, Korea, Saudi, GNE, Egypt, EU, Russia), training, investigations)
o Investments, bought & upgraded approx. 10x Labelers, 9x Casepackers, 2x MAW and 1x PCA40
o L1-3 systems implementations, upgrades, fixes, solving problems, Serialization SuperUser etc
• Quality Assurance Coordinator – Validation & Project Manager
o Management of validation and testing activity in GMS Poznan.
o As Project Manager responsible for implementing the following systems:
Travel Expenses Management in SAP ERP
Learning Management System for compliance training
Controlled Document Management System for validation documents
PPA – Product Performance Assessment GxP Trending Tool
• SAP Upgrade Project Manager (from January 2009 till March 2010)
o Responsibility: Leading one of the biggest IT Project in recent years – upgrade of SAP ERP from 4.6c to 6.0. Management the team of 50 people including internal and external consultants.
• Quality Assurance Coordinator / Validation manager (from October 2005)
o Management of validation and testing activity including clean rooms, engineering systems, equipment, processes, cleaning methods, automation systems, laboratory systems and IT systems.
• Computer System Validation Leading Validation Specialist
o Introduction from scratch validation documentation for computerised systems (control, laboratory and IT systems).
The Pop in your Job:
• Serialisation requires large knowledge regarding IT systems, automation, processes and validation that’s why its greate opportunity to learn and develop
• I am fully independent and responsible for all serialization aspects at my Delpharm Poznan site that’s also a lot of responsibility
• Due to my Automation Education I like to spend some time at production lines / machines doing tests, trials, investigations and helping solving problems