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Computerised System Validation Specialist, prov. Ravenna. Italy
Gruppo MAASI —Faenza, Emilia-Romagna
- Inglese

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Computerised System Validation Specialist, prov. Ravenna. Italy

Gruppo MAASI
Faenza, Emilia-Romagna

Candidati adesso

Dettagli della posizione

Tempo indeterminato

Qualifiche

Inglese
Italiano

Descrizione completa della posizione

Faenza, Italy

We are looking for Computer System Validation specialist with operational experience in the Life Sciences sector on behalf of our internationally renowned client.

The ideal candidate will be responsible for:

Independently managing the activities of test ideation and execution.
Assisting the client in software system validation.
Drafting validation plans, conducting tests, collecting and evaluating results, and preparing validation reports.

For mid and senior roles, ideal candidates must have proven experience as a consultant in the pharmaceutical and/or biotech industry.

Minimum Seniority

Technical

Commercial

Quality Assurance

Administration

Position details

Main location: Prov. Imola
Employment type: Permanent Contract
Hours of work: Monday to Friday, 9 am to 6 pm
Reporting to: Project leader
Salary range: Depending on skills and experience

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.

Essential 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.

What We Offer

Great career development opportunities.
Internal and external training programs.
Performance bonuses.
Comprehensive welfare package.
Meal vouchers.
Overtime pay in accordance with regulations.
Team building activities.

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.

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.

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