CSV specialist MID/Senior
pWe are looking for a Mid – to bSenior CSV Specialist /b (Computerised System Validation) to join our team and provide consulting services to clients operating in the Life Sciences sector. /ppThe successful candidate will be responsible for: /pulliDefining and leading validation strategies for complex computerised systems supporting regulated facilities and processes, ensuring regulatory compliance and Data Integrity throughout the entire system lifecycle. /liliActing as a technical and strategic point of reference for stakeholders and senior management, while overseeing and coordinating project activities. /li /ulh3MINIMUM SENIORITY /h3h3TECHNICAL /h3h3COMMERCIAL /h3h3QUALITY ASSURANCE /h3h3ADMINISTRATION /h3ulliLocation: /liliTravel: /liliYES, at least 30% /liliContract Type: /liliPermanent /liliWorking Hours: /liliMon-Fri 9-18 Flexible hours /liliSalary range: /liliGross annual salary from €32,000 to €54,000, plus company welfare benefits and performance bonuses in accordance with company policy. /liliDepartment: /liliQuality Assurance - Life Science /liliReporting to: /liliWe offer an excellent growth opportunity /li /ulh3Main responsibilities /h3pDefine validation strategies and manage Change Control and Periodic Reviews for computerised systems.br/Conduct Impact and Risk Assessments (GAMP / Data Integrity) and develop IT/OT qualification plans.br/Prepare and approve validation documentation, including Validation Plans, Validation Reports, User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS).br/Develop and support the execution of tests for Commissioning, FAT/SAT and IQ/OQ/PQ protocols.br/Prepare and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs) and related training plans. /ph3Requirements /h3pProven experience in consultancy within the Life Sciences sector.br/Excellent knowledge of GxP standards, GAMP 5, FDA 21 CFR Part 11 and EudraLex Volume 4,
Annex 11.br/Extensive experience in preparing and reviewing regulated technical documentation.br/Strong organisational skills and the ability to manage priorities across complex projects.br/Excellent interpersonal and communication skills, with the ability to liaise effectively with multidisciplinary teams and senior management.br/Fluency in both English and Italian (C1 level or above), written and spoken. /ph3Nice to have /h3pExperience in the validation of specific application systems such as MES, LIMS, ERP, DCS and SCADA.br/Understanding of the relationship between IT/OT architectures and computerised systems.br/Familiarity with Cloud environments and SaaS solutions in regulated environments.br/Knowledge of cybersecurity principles applied to computerised systems in GxP environments.br/Experience with Electronic Document Management Systems (EDMS) and computerised system lifecycle management tools.br/Knowledge of Computer Software Assurance (CSA) methodologies.br/Experience in managing regulatory audits and inspections. /ph3What We Offer /h3pA comprehensive training program that includes: /pulliFlexible working hours and remote working. /liliInternal and external training programs. /liliPerformance bonuses. /liliTeam building activities. /li /ulpMAASI Enterprises want to be an inclusive and equitable company, we value differences, and welcome people from all walks of life. /ppWe believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit. /ph3Rewarding /h3pA salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base. /ph3Trainings /h3pInternal and external trainings specifically selected on your aptitudes and talent. /ppA set of benefits, services and affiliations on top to the profession's health insurance. /ph3we're Humans /h3pWe're a Company of human beings, before anything else. You'll never be "just a number" here. /p #J-18808-Ljbffr
Annex 11.br/Extensive experience in preparing and reviewing regulated technical documentation.br/Strong organisational skills and the ability to manage priorities across complex projects.br/Excellent interpersonal and communication skills, with the ability to liaise effectively with multidisciplinary teams and senior management.br/Fluency in both English and Italian (C1 level or above), written and spoken. /ph3Nice to have /h3pExperience in the validation of specific application systems such as MES, LIMS, ERP, DCS and SCADA.br/Understanding of the relationship between IT/OT architectures and computerised systems.br/Familiarity with Cloud environments and SaaS solutions in regulated environments.br/Knowledge of cybersecurity principles applied to computerised systems in GxP environments.br/Experience with Electronic Document Management Systems (EDMS) and computerised system lifecycle management tools.br/Knowledge of Computer Software Assurance (CSA) methodologies.br/Experience in managing regulatory audits and inspections. /ph3What We Offer /h3pA comprehensive training program that includes: /pulliFlexible working hours and remote working. /liliInternal and external training programs. /liliPerformance bonuses. /liliTeam building activities. /li /ulpMAASI Enterprises want to be an inclusive and equitable company, we value differences, and welcome people from all walks of life. /ppWe believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit. /ph3Rewarding /h3pA salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base. /ph3Trainings /h3pInternal and external trainings specifically selected on your aptitudes and talent. /ppA set of benefits, services and affiliations on top to the profession's health insurance. /ph3we're Humans /h3pWe're a Company of human beings, before anything else. You'll never be "just a number" here. /p #J-18808-Ljbffr