We 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 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 www.KVALITO.chLife Science Consultant, Validation Engineering InternLocation: SpainResponsibilitiesThe Validation Engineering Intern will learn and gain practical experience in a hands-on environment while providing support to our clients.The Validation Engineering Intern will support deployment and upgrading custom and COTS applications by authoring change controls, risk assessments, integration protocols, test scripts and summary reports and by updating SOPs, training material and equipment asset care activities as required.The Validation Engineering Intern will support (Senior) Life Science Consultants and provide guidance to the project team on up-to-date and relevant regulatory requirements. They will work closely with various members of the project team and business process owners to ensure systems are deployed and rolled out, and that upgrades are executed and delivered in a timely manner.The Validation Engineering Intern will develop and promote good practices to continuously improve the quality and effectiveness of the Engineering and IT processes, achieving the appropriate level of regulatory compliance and act in close partnership with all stakeholders to ensure consistency in the quality approach, including:Third Parties Quality ManagementInternal Control and Risk ManagementPredictive Compliance Planning and RemediationWeekly and Monthly dashboardsSupport updating of SOPsReview & Approvals of SDLC documentation in line with SDLC requirementsEnsure inspection readiness of the projectMinimum Qualifications And ExperienceA degree in Engineering, Computer Science, or related discipline / equivalent experience.Ability to work without direct supervision within a complex project team.Strong verbal and written communication skills.Background in software development and test with an in-depth understanding of relevant GAMP and relevant EU/FDA regulations around software and data systems is a plus.Knowledge of GxP and GDP practices, 21 CFR Part 11, and good working knowledge of Data Integrity is a plus.We 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 Recruiting(at)kvalito.ch including your:CV, cover letter and supporting documents (i.e. diplomas, certificates, references)Availability - earliest start dateAbility to travelSalary expectationsLocation preference in EuropeWe are looking forward to your application.Your KVALITO Team.
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