PSenior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise (Pescara, 65124), (Reggio Calabria, 89100), (naples, 34112), (Bologna, 40100), (Bagno Di Romagna, 47021), Abruzzo, Calabria, Campania, Emilia-Romagna, Lazio, Sardinia - Italy | Posted - 13 / 07 / 23 Overview /ppbWe are looking for enthusiasts /b /ppKVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries withafocus 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 industrybest practicesand 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 /ppOnly candidates located within the European Union (EU) will be considered for this position. /ppbDuration : 6 months (withthe possibility of extension) /b /ppWe 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 AL solutions, including the utilization of Open AI technologies like ChatGPT, and demonstrate the ability to develop robust testing strategies for these systems. /ppbResponsibilities /b /pulliProviding consultation services to our clients in the pharmaceutical industry, with a specific focus on computer system validation (CSV) and AI solutions /liliDevelop, implement, and maintain AI solutions using technologies like Open AI's ChatGPT. /liliFeed internal procedures documents into AI systems, ensuring the system accurately identifies the source. /liliDeliver insights on regulatory differences across various countries and present these findings through clear and concise reports and graphical representations. /liliDevelop and execute validation deliverables, including requirements, compliance / validation plans, test protocols, test summary reports, and compliance / validation reports. /liliReview and approve system tests, user acceptance test scripts, traceability matrices, and design specifications. /liliDesign and understand test plans, system, and UAT test scripts, and test procedures for AI solutions. /liliProvide guidance on validation, conduct timely reviews, and escalate to TQ management when necessary. /li /ulpMinimum Qualification and Experience /ppbEducation /b /pulliBachelor’s degree in computer science, Data Science, or a related field. /liliMaster’s degree is preferred. /li /ulpbLanguage /b /pulliFluent in English (oral and written) is a requirement. /liliAny additional language is plus. /lili3+ years of experience in Computer System Validation. /lili2+ years of experience with System development Lifecycle. /liliPrior experience in the Pharmaceutical, Biotechnology, or Medical Device industry. /liliFamiliarity with FDA regulations and global regulatory environments. /liliUnderstanding of GxP standards and risk-based validation. /li /ulpHard Skills /ppbMust Have : /b /pulliExperience in FDA and / or Global regulated environment with a good understanding of GxP standards and Risk-based validation. /liliProficient knowledge of FDA guidance and industry standards (i.e., GAMP). /liliIn-depth knowledge and practical experience with AI technologies, specifically Open AI's ChatGPT. /liliProven experience with AI testing strategies and understanding AI models. /liliQA methodologies and the ability to design, review, and approve test plans, scripts, and procedures. /li /ulpbNice to Have : /b /pulliExceptional organizational and multitasking skills. /liliProven ability to lead a team and work independently. /li /ulpbSoft Skills /b /pulliStrong written and verbal communication skills /liliAbilityto work as a team player, lead a team, or complete tasks independently. /liliStrong attention to detail and ability to ensure data accuracy and reliability. /liliCapability to work with remote teams and support multiple projects simultaneously. /li /ulpbWe offer great benefits /b /pulliFlat hierarchies and responsibility from the beginning /liliPeople-oriented culture /liliDiversity and inclusion-focused environment /liliGlobal client projects in a multinational environment /liliFlexible working hours and home office /liliIndividual professional development, training, and coaching /liliUnlimited full employment contract /liliExcellent remuneration package consisting of a competitive salary plus a substantial bonus. /li /ulpbContact /b /ppIf 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 torecruiting(at)kvalito.ch including your : /pulliCV, cover letter, and supporting documents(i.e.,diplomas, certificates, references) /liliAvailability - earliest start date /liliSalary expectations /liliLocation preference /li /ulpWe are looking forward to your application. /ppYour KVALITO Team. /ppLife Science Consultant, Senior Computer System Validation (AI Focus) /ppLife Science Consultant, Senior Computer System Validation (AI Focus) /ppLife Science Consultant, Senior Computer System Validation (AI Focus) /ppLife Science Consultant, Senior Computer System Validation (AI Focus) /ppLife Science Consultant, Senior Computer System Validation (AI Focus) /ppJ-18808-Ljbffr /ppSenior Consultant • Abruzzo, Pescara, Italia /p #J-18808-Ljbffr