Computerised System Validation Specialist, prov. Ravenna. Italy

Technical

Commercial

Quality Assurance

Administration

- 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:

- Courses and professional certifications on reference solutions.
- Preparatory training in the company with a structured program.
- Training alongside experienced personnel with proven expertise.
And:
- Performance-based incentives upon reaching work autonomy.

MAASI Enterprises want to be an inclusive and equitable company, we value differences, and welcome people from all walks of life.

We believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit.

Rewarding

A salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base.

Trainings

Internal and external trainings specifically selected on your aptitudes and talent.

A set of benefits, services and affiliations on top to the profession's health insurance.

we're Humans

We're a Company of human beings, before anything else. You'll never be "just a number" here.

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