ph3Computerised System Validation Specialist, prov. Ravenna. Italy /h3 h3Technical /h3 h3Commercial /h3 h3Quality Assurance /h3 h3Administration /h3 ul liLocation: /li liTravel: /li liNO /li liContract Type: /li liWorking Hours: /li liLun-Ven 9-18 /li liSalary range: /li liDepending on the actual experience achieved. /li liDepartment: /li liLife Sciences / Quality Assurance /li liReporting to: /li liProject leader /li liWe offer an excellent growth opportunity /li /ul h3Main responsibilities /h3 p– Definition and drafting of Validation Plans, Validation Reports, Test Plans, Acceptance Criteria, User Requirements, etc.br/– Writing and reviewing Standard Operating Procedures and work instructions.br/– Preparation of Technical Specification documents (Design and Functional) in collaboration with process or solution engineers, and management of revisions and approval workflows.br/– Writing and executing IQ/OQ/PQ test protocols for computerised systems, processes, equipment and utilities.br/– Execution of technical Impact Assessments.br/– Writing and reviewing calibration and maintenance Plans.br/– Writing and reviewing plans, tests, and procedures related to the qualification of IT/OT infrastructures. /p h3Requirements /h3 p– High level of knowledge of pharmaceutical industry standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc).br/– Excellent verbal and written communication skills: Italian and English at CEFR C1 level or higher (reading, writing,



and speaking – the interview will be conducted in both languages).– Utmost professionalism and seriousness, ability to maintain a distinguished and formal approach towards clients and colleagues.– Excellent technical and communication skills and a strong motivation. /p h3Nice to have /h3 h3What We Offer /h3 pA comprehensive training program that includes: /p ul liCourses and professional certifications on reference solutions. /li liPreparatory training in the company with a structured program. /li liTraining alongside experienced personnel with proven expertise.br/And: /li liPerformance-based incentives upon reaching work autonomy. /li /ul pMAASI Enterprises want to be an inclusive and equitable company, we value differences, and welcome people from all walks of life. /p pWe believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit. /p h3Rewarding /h3 pA salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base. /p h3Trainings /h3 pInternal and external trainings specifically selected on your aptitudes and talent. /p pA set of benefits, services and affiliations on top to the profession's health insurance. /p h3we're Humans /h3 pWe're a Company of human beings, before anything else. You'll never be "just a number" here. /p /p #J-18808-Ljbffr

📌 Computerised System Validation Specialist, prov. Ravenna. Italy
🏢 MAASI Enterprises
📍 Ravenna