Computerised System Validation Specialist, Prov Pisa

Computerised System Validation Specialist, Prov
Pisa
Toscana, 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 + 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!