.Senior Life Science Consultant - Senior Computer System Validation Consultant with AI ExpertiseLocation: Various locations in SpainPosted: 13 / 07 / 23OverviewWe are looking for enthusiasts.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.For more information, please visit us at www.KVALITO.Ch.Life Science Consultant: Senior CSV (AI Focus)Only candidates located within the European Union (EU) will be considered for this position.Duration: 6 months (with the possibility of extension)We are seeking a highly skilled and motivated senior CSV consultant with expertise in AI to join our team. The ideal candidate should have proven experience with system development, lifecycles, computer system validation, and regulatory standards.Additionally, the candidate should possess extensive knowledge in AI solutions, including the utilization of Open AI technologies like ChatGPT, and demonstrate the ability to develop robust testing strategies for these systems.ResponsibilitiesProviding consultation services to our clients in the pharmaceutical industry, with a specific focus on computer system validation (CSV) and AI solutions.Develop, implement, and maintain AI solutions using technologies like Open AI's ChatGPT.Feed internal procedures & documents into AI systems, ensuring the system accurately identifies the source.Deliver insights on regulatory differences across various countries and present these findings through clear and concise reports and graphical representations.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.Provide guidance on validation, conduct timely reviews, and escalate to TQ management when necessary.Minimum Qualification and ExperienceEducationBachelor's degree in computer science, Data Science, or a related field.Master's degree is preferred.LanguageFluent in English (oral and written) is a requirement.Any additional language is a plus.Work experience3+ years of experience in Computer System Validation.2+ years of experience with System Development Lifecycle.Prior experience in the Pharmaceutical, Biotechnology, or Medical Device industry.Familiarity with FDA regulations and global regulatory environments.Understanding of GxP standards and risk-based validation
