Company Description\n\nWe are the designers of today for the world of tomorrow.\n\nAs one of the world's leading development service providers, we at ALTEN are committed to positively shaping the future of our partners, the careers of our employees, and the challenges for our society and environment.\n\nMore than 50,000 employees in 30 countries are already working on innovative solutions in various engineering and IT sectors such as automotive, mechanical engineering, plant engineering, semiconductors, railway technology, aerospace, renewable energies, and medical technology.\n\n## Job Description\n\nYou...\n\n* are responsible for the review and auditing of IT systems, software, and validated processes for FDA 21 CFR Part 11 compliance\n* conduct GAP analyses and risk assessments for data integrity\n* document audit results and create CAPA plans (Corrective and Preventive Actions)\n* advise on the implementation of electronic signature processes\n\n## Qualifications\n\nYou...\n\n* have a degree in Life Sciences, Computer Science, Engineering, or a comparable field\n* have sound knowledge of FDA regulations ((21 CFR Part 11, Part 820/QSR) and GMP\n* have experience in Computer System Validation (CSV)\n* have prior auditing experience (internal/external) in regulated industries\n* speak fluent German and English\n\nWe value diversity and therefore welcome all applications -- regardless of gender, nationality, ethnic and social origin, religion/belief, disability, age, and sexual orientation and identity.\n\nSeverely disabled applicants will be given preferential consideration if equally qualified.\n\nStill have questions?\n\nThen contact me: Maja Crepulja (Tel.: 49 89 255552-296)\n\nOr apply now via our online application form.\n\n## Additional Information\n\n* Talent Management -- we develop your career\n* Work Life Balance -- flexible working hours and mobile working possible\n* Fit and relaxed -- with EGYM Wellpass\n* Enjoy biking -- always on the go with company bike leasing\n* Green Mobility -- travel at a discount with us\n\n...in addition, we offer a permanent employment contract, corporate benefits, and team events.\n\n* Benefits:\n * Talent Management\n * Work Life Balance\n * Fit and relaxed\n * Enjoy biking\n * Green Mobility\n * Permanent employment contract\n * Corporate Benefits\n * Team events
