GMP Expert (m/f)
Thinking Industry further
Siemens Digital Industries is the innovation and technology leader in industrial automation and digitalization. Together with our partners and customers we drive Digitalization in both the discrete and the process industry, enabling flexibility, efficiency, and reduced time to market. Digital transformation paves the way for innovation, services, and new data-based business models.
What part will you play?
As Senior GMP Consultant, you are part of the VM Pharma Team, a Siemens Stammhaus unit focusing on Pharma customers.
Your mission is to trace pharmaceutical requirements stipulated in regulations and best practices and support our product development teams and solution teams to meet these requirements. Communicate how Siemens products and solutions comply with pharma requirements.
The position also focuses on new technology envisioned by the pharmaceutical industry and their fit to the regulatory requirements.
The key objectives are:
- You trace pharmaceutical regulations and best practices and potential impact on products and/or services
- You communicate the results to the Siemens organization
- Providing templates and tools for the GxP-compatible execution of projects in GxP-regulated areas, such as validation standards, training material, tools for validation tasks
- You are providing sales-supporting materials and tools regarding the use of Siemens' products and/or services in GxP-regulated areas
- You support pre-sales activities with GxP-focus
- You support GxP-topics in critical projects
What you need to make real what matters.
- You have a University degree in IT or similar field
- Expert knowledge on pharmaceutical regulations from the most influencing agencies and organizations (US FDA, European EMA, ICH, PIC/S, ISPE and its GAMP CoP)
- Expert knowledge of the pharmaceuticals industries requirements on the execution of automation and IT-projects, GAMP5 and other relevant standards and initiatives (e.g. QbD/PAT)
- You have experience in GxP regulated projects, in the areas of validation and/or project management
- You have knowledge in the area of DCs and MES systems
- You have exceptional analytical and conceptual thinking skills
- Furthermore, you are experienced in cross-regional and cross-cultural projects and therefore, you have an excellent knowledge of English; fluent German skills are a plus
Make your mark in our exciting world at Siemens.
