Senior Life Science Consultant

hace 2 días


Andalucía, España Johnson & Johnson A tiempo completo

Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise (Andalusia, ), (Zaragoza, 50001), (Santander, 39001), (León, ), (A Coruna, ), Cantabria, Andalusia, Aragon, Castille and León, Galicia - Spain | Posted - 13 / 07 / 23 KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland, Italy, and Malaysia. With our enthusiasm for progressive technologies and our in‑depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. Life Science Consultant: Senior CSV (AI Focus) Providing consultation services to our clients in the pharmaceutical industry, with a specific focus on computer system validation (CSV) and AI solutions Develop and execute validation deliverables, including requirements, compliance/validation plans, test protocols, test summary reports, and compliance/validation reports Review and approve system tests, user acceptance test scripts, traceability matrices, and design specifications Design and understand test plans, system and UAT test scripts, and test procedures for AI solutions Bachelor’s degree in computer science, Data Science, or a related field Master’s degree is preferred Fluent in English (oral and written) is a requirement Prior experience in the Pharmaceutical, Biotechnology, or Medical Device industry ~ Familiarity with FDA regulations and global regulatory environments ~ Experience in FDA and/or Global regulated environment with a good understanding of GxP standards and Risk-based validation Proven experience with AI testing strategies and understanding AI models QA methodologies and the ability to design, review, and approve test plans, scripts, and procedures Strong attention to detail and ability to ensure data accuracy and reliability Capability to work with remote teams and support multiple projects simultaneously Global client projects in a multinational environment Flexible working hours and home office Involvement in global conferences Individual professional development, training, and coaching Unlimited full employment contract If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to including your: CV, cover letter, and supporting documents (i.e.,



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    Overview Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise (Andalusia, ), (Zaragoza, 50001), (Santander, 39001), (León, ), (A Coruna, ), Cantabria, Andalusia, Aragon, Castille and León, Galicia - Spain | Posted - 13 / 07 / 23 We are looking for enthusiasts KVALITO Consulting Group is a strategic partner and...

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