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Project Manager
GMP
Projektledare
Gbg
The CDC (Continuous Direct Compression) project is about introducing continuous manufacturing, a new manufacturing technique. The IT part of this strategic business project is about implementing a Process Analytical Technology (PAT) Management system, (SIPAT from Siemens), that communicates with the manufacturing equipment and the instruments measuring quality of the product during the process. The implemented system must be validated for GMP use, which mean the ITPM should have knowledge and experience of GMP validation or similar regulatory validation activities and documentation related to that on top of project management skills. The IT project is a sub project to the business project, which are introducing new manufacturing equipment, so the ITPM also need to work closely with the Business Project Manager to make sure dependencies and deliveries are aligned. The CDC project is expected to run until Q4 2020. The GAT (Genuair Automation Technique) project is about introducing a new inhalation device testing robot to Sweden Operations (SweOps). The robot is developed by PT&D in Gothenburg and contains a software product from the supplier Brooks. The software, will be slightly adjusted before it can be introduced at SweOps. This project is also about GMP validation and as parts of the project team and the experience from the Gothenburg implementation, is available in Gothenburg, it should be suitable for the ITPM to be in Gothenburg. The GAT project is expected to be done by March 2020. Qualifications: Senior Project Manager, Validation experience and GxP documentation knowledge, fluent in English (spoken and written).

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