Computerised System Validation Specialist, prov. Ravenna. Italy

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  • Prov. Imola / Faenza, Italia

Ricerchiamo per un nostro cliente di rilevanza internazionale, due specialisti in Computer System Validation con esperienza operativa nel settore Life Sciences.

Il candidato ideale dovrà:

  • Curare in autonomia le attività di ideazione ed esecuzione di test
  • Supportare il cliente nella convalida del sistema software
  • Redigere piani di validazione, realizzare test, raccogliere e valutare risultati, redigere rapporti di convalida

Per i ruoli mid e senior, i candidati ideali devono aver maturato una comprovata esperienza come consulente in ambito farmaceutico e/o biotech.

Minimum Seniority
Technical
Commercial
Quality Assurance
Administration

Position details

  • 📍 Location:
  • Prov. Imola / Faenza, Italia
  • 🛫 Travel:
  • NO
  • 💼 Contract Type:
  • Contratto a tempo indeterminato
  • 📋 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: 
  • Welfare plan scheme.
  • Ticket lunch.
  • 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. 
If you are ready to take on an exciting challenge and be part of a dynamic team in the pharmaceutical consulting industry, do not hesitate to send us your application.


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.

Apply now