Computerised System Validation Specialist, prov. Parma (Italy)

Pisa, Italy

We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. 

The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically in CSV (Computerised System Validation), validation protocols, and Validation Plan, IQ/OQ/PQ processes.


  • 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.
  • All candidates must have demonstrated experience in the pharmaceutical and/or biotech sectors.
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


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.