20 ago
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Gruppo MAASI
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Pisa
**_Pisa_**_, _**_Italy_**_ _**
**We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists.
- Independently manage the design and execution of tests.
- Provide client support in software system validation.
- Develop validation plans, conduct tests, collect and evaluate results, and prepare validation reports. **Minimum Seniority**:
**Technical**:
**Commercial**:
**Quality Assurance**:
**Administration**:
**Position details**: - **Location: On site, Parma (3 vacancies: 1 Senior, 2 Junior/Mid)**: - ** Type: Permanent, Full time,**: - ** Reports to: Project Leader**: - ** Level and salary: Depending on the actual experience achieved + premio, training and Welfare plan.** **Responsibilities**:
- Defining and writing Validation Plans, Validation Reports, Test plans, Acceptance tests, User Requirements, etc.
- Management of Change Control and Periodic Review processes.
- Conducting Data Integrity Assessments.
- Writing and reviewing Standard Operating Procedures and Work Instructions.
- Drafting of Design and Functional Specification documents in cooperation with our System or Process Engineers and managing formal revision and approval processes.
- Writing and executing IQ/OQ/PQ test protocols for computer systems, processes, equipment and utilities.
- Performing Technical Impact Assessments.
- Writing and reviewing Calibration and Maintenance Plans.
- IT/OT Infrastructure Qualification plan, tests and procedures writing and review. **Requirements**: - Very good knowledge of pharma standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc.).
- Language skills: Italian and English CEFR C1 level or higher (read, written and spoken - the interview will be held in both languages).
- Utmost professionalism and seriousness towards customers and colleagues. **What We Offer**: - Broad career development opportunities
- Internal and external training programs
- Performance bonuses
- Comprehensive welfare package
- Meal vouchers
- Overtime pay in compliance with regulations
- Team building activities **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. **Welfare plan**:
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.
- CANDIDATI ORA!
📌 Computerised System Validation Specialist, Prov (Pisa)
🏢 Gruppo MAASI
📍 Pisa