Computerised System Validation Specialist, prov. Parma

1 mese fa

Parma, Italia MAASI Enterprises Ltd A tempo pieno

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.

Responsibilities

  • 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.
  • 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

  • Internal and external training programs
  • Performance bonuses
  • 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.

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