PJoin to apply for the strongSenior CSV Consultant /strong role at strongfortil /strong /pp4 days ago Be among the first 25 applicants /ppJoin to apply for the strongSenior CSV Consultant /strong role at strongfortil /strong /ppFortil is an engineering consulting group active across Europe since 2009. We support our partners in the success of their technical projects in various sectors such as Industry, IT, and Care.brToday, we are more than 2,700 employees across 11 countries. Working with us means being part of an ambitious team in a multicultural and international environment!brOur ambition is to help build a more responsible, supportive and inclusive world for our employees and clients.brWe are currently seeking astrong strongSenior Computer System Validation (CSV) Consultant /strong /strongto join our growing team instrong strongCampania /strong.br/strongstrongResponsibilitiesbr/strongulliValidation of computerized systems in the Life Science sector (e.g. laboratory instrumentation control systems, automation systems and quality systems - ERP, LIMS, DMS - according to the GxP reference regulations and GAMP Guidelines; /liliSupport in the management of remediation or requalification projects for the adaptation of computerized systems to the FDA 21 CFR part 11/EU Annex 11 regulations and to the Data Integrity regulations and guidelines; /liliPeriodic review of computerized systems and user audit trails; /liliDrafting of validation documents: Validation Plans, URS, Traceability Matrices; /liliDrafting and execution in the field of test protocols: IQ/OQ/PQ; /liliDrafting of Risk Assessments; /liliDrafting of computerized system administration procedures;br/li /ulstrongAbout Youbr/strongulliBachelor's or Master's degree in technical-engineering or similar subjects (Chemical Engineering, Chemistry, Industrial Chemistry, Mechanical Engineering, CTF, Pharmacy, Biology); /lili5+ years of experience on CSV projects in the Life Science field; /liliSkilled in mapping data flows and performing gap analyses to identify compliance and process improvement opportunities /liliGood knowledge of the reference regulations and guidelines. In particular, knowledge of GMP, CFR 21 Part 11 Regulations, EU/GMP Annex 11, ISPE GAMP5; guidelines, data integrity regulations and guidelines (e.g. MHRA, WHO, EMA, FDA) and ICH guidelines, in particular ICHQ9, is required; /liliGood knowledge of the English language, both written and spoken; /liliExcellent knowledge of the Office package;br/li /ulstrongNext Stepsbr/strongulliSomeone from the Talent Acquisition department will contact you to schedule an initial HR interview. /liliIf successful, a second interview will be conducted to validate your technical knowledge. /liliIn case of a positive outcome from the technical interview, there will be a last qualification meeting with the Client. /liliIf the final outcome is positive, we will discuss our proposal with you. Alternatively, if the outcome is negative, we will share our sincere feedback!br/li /ulstrongWhy Fortil?br/strongAlthough we currently find ourselves in a significant phase of expansion, the high standards of our projects and recruitments remain as demanding as ever. Quality will always take precedence over quantity, as we prefer excellence to ease!brWe hope to become the largest independent engineering group in Europe, working to serve future generations. To do so, our operational model is based on four fundamental aspects:brulliProfitable performance /liliExpert engineers /liliEfficient organisation /liliSocial responsibilitybr/li /ulstrongApply and join us to become part of a model that is out of the ordinary! /strong /ph3Seniority level /h3ullih3Seniority level /h3Mid-Senior level /li /ulh3Employment type /h3ullih3Employment type /h3Full-time /li /ulh3Job function /h3ullih3Job function /h3Consulting, Information Technology, and Sales /lilih3Industries /h3Business Consulting and Services /li /ulpReferrals increase your chances of interviewing at fortil by 2x /ppGet notified about new Senior Consultant jobs in strongAprilia, Latium, Italy /strong. /ph3People Consulting - Public Senior Consultant /h3h3Consultant/Senior Consultant - Digital Financial Services (Roma) /h3h3Talent Transformation Senior Consultant /h3pGreater Rome Metropolitan Area 5 days ago /ph3Senior Consultant ambito Function Points Licensing /h3h3CONSULTANT/SENIOR CONSULTANT LETTINGSALES /h3h3Business Technology Consultant/Senior Consultant - Roma /h3h3Senior Consultant - Digital Transformation - Public Sector - ROMA /h3h3Senior Business Analyst Digital Payments /h3h3Senior International Trade Customs Consultant - Roma/Milano /h3h3Operational Excellence Senior Consultant | Milano/Roma /h3h3Public Sector Business Analyst (Consulting) /h3h3Business Transformation Senior Consultant (Transportation Sector more) /h3h3Consultant Change Management - People Consulting - Roma/Milano /h3h3ICT Strategy and Governance Senior/Consultant /h3pWe’re unlocking community knowledge in a new way. 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