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Working Student: Support Software Validation (all genders)
A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Our Pharma Operations organization is currently implementing a Scientific Data Management system (SDM). This software is capable of accessing data from multiple data sources and allows subsequent data analysis and generation of reports in the context of pharmaceutical manufacturing and quality control. As the results are relevant to make decisions in context of Good Manufacturing Practice (GMP) the system needs to be validated according to computerized system validation (CSV) guidelines.
Support the activities of testing and documenting the SDM system according to validation guidelines of computerized software systems, which includes:
Familiarization/training on the basic principles and usage of our scientific data management system based on the commercial software STATISTICA, Review & update of validation documents, such as URS, FRS, risk analysis etc. Manage review and approval workflows of documents, Develop &Write test plans and execute them, Interact with internal and external stakeholders.
- Student of pharmaceutical technology or any other natural or engineering /data science
- Familiar with MS Office Tools, preferably knowledge of statistics software (e.g. Minitab, Statistica, JMP)
- Language skills: English (complete documentation is/will be held in English), preferably German as well
- Preferably basic knowledge of GxP principles
- Preferably basic knowledge/experience in system validation (e.g. V-model approach)
Duration: 6 Months (extension possible)
Frequency: 1-2 days/week
Curious? Apply and find more information at https://jobs.vibrantm.com