**_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 + bonus, 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!