Computerised System Validation Specialist, prov. Ravenna. Italy

La preghiamo di verificare di possedere il livello di esperienza e le qualifiche adeguate leggendo la panoramica completa di questa occasione qui sotto.
Technical
Commercial
Quality Assurance
Administration

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- Location:
- Travel:
- NO
- Contract Type:
- Working Hours:
- Lun-Ven 9-18
- Salary range:
- Depending on the actual experience achieved.
- Department:
- Life Sciences / Quality Assurance
- Reporting to:
- Project leader
- We offer an excellent growth opportunity

Main responsibilities
– Definition and drafting of Validation Plans, Validation Reports, Test Plans, Acceptance Criteria, User Requirements, etc.
– Writing and reviewing Standard Operating Procedures and work instructions.
– Preparation of Technical Specification documents (Design and Functional) in collaboration with process or solution engineers, and management of revisions and approval workflows.
– Writing and executing IQ/OQ/PQ test protocols for computerised systems, processes, equipment and utilities.




– Execution of technical Impact Assessments.
– Writing and reviewing calibration and maintenance Plans.
– Writing and reviewing plans, tests, and procedures related to the qualification of IT/OT infrastructures.

Requirements
– High level of knowledge of pharmaceutical industry standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc).
– 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.

Nice to have
What We Offer
A comprehensive training program that includes:

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- Courses and professional certifications on reference solutions.
- Preparatory training in the company with a structured prog

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