Role & Responsibilities
Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech)
Advisory and support of application owners to build and maintain GxP conform systems
Support and consulting during projects handling GxP critical computer systems
Implementation of qualification / validation activities within projects of new and existing computer systems according to our client requirements
Conception and implementation of Raw-Data-Handling systems and solutions (Data Integrity)
Computer systems according to internal Software Development Lifecycle
Performing internal and external CSV trainings
Position Requirements
University degree in Informatics, Quality, Engineering or another relevant discipline
At least 2-3 years of experience in validation of GxP relevant IT systems such as ERP, MES, LIMS or Quality Systems
Working knowledge of national and international regulations and standards, eg. GAMP5, ISO 9001, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11
Analytical and structured working style; strong attention to detail
Ability to effectively work as part of a multidisciplinary, international team
Hands-on personality, with flexibility and dedication to maximize our client s value
Good verbal and written communication skills in English, German language is a plus
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