Senior Life Science Consultant

OverviewTodos los candidatos deben asegurarse de leer atentamente la siguiente descripción del puesto y la información antes de enviar su solicitud.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 / 23We are looking for enthusiastsKVALITO 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. For more information, please visit us at 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)ResponsibilitiesProviding consultation services to our clients in the pharmaceutical industry, with a specific focus on computer system validation (CSV) and AI solutionsDevelop, implement, and maintain AI solutions using technologies like Open AI's ChatGPTFeed internal procedures and documents into AI systems, ensuring the system accurately identifies the sourceDeliver insights on regulatory differences across various countries and present these findings through clear and concise reports and graphical representationsDevelop and execute validation deliverables, including requirements, compliance/validation plans, test protocols, test summary reports, and compliance/validation reportsReview and approve system tests, user acceptance test scripts, traceability matrices, and design specificationsDesign and understand test plans, system and UAT test scripts, and test procedures for AI solutionsProvide guidance on validation, conduct timely reviews, and escalate to TQ management when necessaryQualificationsEducationBachelor’s degree in computer science, Data Science, or a related fieldMaster’s degree is preferredLanguageFluent in English (oral and written) is a requirementAny additional language is a plusWork experience3+ years of experience in Computer System Validation2+ years of experience with System Development LifecyclePrior experience in the Pharmaceutical, Biotechnology, or Medical Device industryFamiliarity with FDA regulations and global regulatory environmentsUnderstanding of GxP standards and risk-based validationHard SkillsMust Have:Experience in FDA and/or Global regulated environment with a good understanding of GxP standards and Risk-based validationProficient knowledge of FDA guidance and industry standards (i.e., GAMP)In-depth knowledge and practical experience with AI technologies, specifically Open AI's ChatGPTProven experience with AI testing strategies and understanding AI modelsQA methodologies and the ability to design, review, and approve test plans, scripts, and proceduresNice to Have:Exceptional organizational and multitasking skillsProven ability to lead a team and work independentlySoft SkillsStrong written and verbal communication skillsAbility to work as a team player, lead a team, or complete tasks independentlyStrong attention to detail and ability to ensure data accuracy and reliabilityCapability to work with remote teams and support multiple projects simultaneouslyWe offer great benefitsFlat hierarchies and responsibility from the beginningPeople-oriented cultureDiversity and inclusion-focused environmentGlobal client projects in a multinational environmentFlexible working hours and home officeInvolvement in global conferencesIndividual professional development, training, and coachingUnlimited full employment contractExcellent remuneration package consisting of a competitive salary plus a substantial bonusContactIf 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., diplomas, certificates, references)Availability - earliest start dateSalary expectationsLocation preferenceWe are looking forward to your application. xsgfvud Your KVALITO Team.#J-18808-Ljbffr