Junior It & Compliance Consultant (Life Sciences)
hace 1 día
Vitoria-Gasteiz
Join Qualitice – Junior IT & Compliance Consultant (Life Sciences) Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación. Launch your consulting career in Digital Quality & Compliance. Are you passionate about technology, digital transformation and the pharmaceutical industry? Do you want to work on international projects while learning from experienced consultants? At Qualitice, we help leading pharmaceutical, biotechnology and medical device companies deliver compliant digital transformation programmes. Our projects combine IT, Quality, Compliance and Project Management in highly regulated environments. We're looking for a motivated Junior IT & Compliance Consultant (m/f/d) to join our growing team and develop into a future Computer System Validation (CSV), Computer System Assurance (CSA) or Digital Quality Consultant. No prior CSV experience is required—we'll provide comprehensive training and mentoring. What You'll Be Doing • Supporting Computer System Validation (CSV) and Computer System Assurance (CSA) projects, • Assisting with validation documentation, testing and quality reviews, • Supporting implementation projects for systems such as ERP, Veeva, LIMS, MES and eQMS, • Participating in GxP risk assessments, supplier assessments and Data Integrity activities, • Coordinating project tasks and collaborating with international client teams, • Researching and applying regulatory requirements such as GxP, GAMP 5, Annex 11 and 21 CFR Part 11, • Supporting audit and inspection readiness activities, • Learning from experienced consultants while taking on increasing responsibility What We're Looking For • Bachelor's or Master's degree in one of the following:, • Computer Science, • Information Technology, • Engineering, • Life Sciences, • Pharmacy, • Biotechnology, • Biomedical Engineering, • Business Informatics, • or a related discipline, • Strong interest in digital transformation, IT and regulated industries, • Excellent analytical and problem-solving skills, • Proactive, structured and eager to learn, • Comfortable working in an international environment, • Fluent English (required), • German is desirable and a significant advantage., • Knowledge of pharmaceutical processes, quality management or software validation is a plus, but not required. What you'll learn • Computer System Validation (CSV) and Computer System Assurance (CSA), • GAMP 5 (Second Edition), • GxP Compliance, • Data Integrity, • Risk Management, • Project Management, • Leading enterprise platforms such as SAP, Veeva, LIMS and MES Why join Qualitice? • Work with leading international pharmaceutical, biotechnology and medical device companies, • Flexible remote-first working model, • Opportunities to travel across Germany, Switzerland and Europe, • Structured mentoring by experienced senior consultants, • Fast professional development with increasing responsibility, • Join a growing specialist consultancy focused on Digital Quality & Compliance, • Friendly, international and entrepreneurial team culture Remote (Europe) with occasional travel to client sites. Candidates must be legally authorised to work within the European Union. Competitive salary based on experience, plus excellent opportunities for professional development. xcskxlj Please send your CV or LinkedIn profile together with a short introduction to . Tell Us About • Why you're interested in consulting, • Your availability, • Your language skills, • Your preferred working location #J-18808-Ljbffr