Job Description
Computer System Validation Associate
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Posting Start Date:  9/23/25
Country/Region:  Italy
State/Province: 
Job Location:  Castelvecchio P.li
Place of Employment: 
Contract Duration:  Permanent
Computer System Validation Associate

At Kedrion, we believe that innovation and care must go hand in hand. Our mission is to enhance lives through our dedicated work in the field of rare and ultra-rare diseases.

As a global leader with a passionate team of 5,200 employees, we collect and fractionate plasma to produce and distribute 38 vital medicines worldwide, establishing ourselves as the fifth largest player in the plasma-derived products sector.

 

Position Purpose

You will play a key role in defining and maintaining quality standards for Computer System Validation (CSV) at Group level, ensuring compliance with GXP regulations and corporate quality standards.
You will collaborate on validation and go-live projects for strategic information systems.

 

Main responsabilities:

 

  • Collaborate in the drafting of the documentation necessary for the validation of the SW systems through the preparation of the IQ, OQ, and PQ protocols of the GMP impact software.
  • Collaborate with SW suppliers for the preparation of validation protocols.
  • Analyze and manages change requests related to computerized systems.
  • Performs the periodic review of Global Computer systems, collaborating with other impacted functions to assure the compliance with regulation, is fit for its intended use and satisfies company policies and procedures.
  • Manages CAPA related to Global Computer System
  • Carry out constant updates on the Regulations and Guidelines issued by regulatory bodies and GXP organizations in the sector of competence, proposing any updates for the implementation of the same on Policies and procedures at group level.
  • Draft and/or update departmental SOPs related to their scope.
  • Audit IT system suppliers.
  • Participate in CSV projects for computerized systems, at group level.
  • Support the execution of software qualification tests.

 

Requirements:

 

  • Scientific Degree
  • at least 1-3 years experience in CSV
  • Proficiency in English (written and spoken)

This announcement is addressed to applicants of both sexes (L. 903/77 - D.Lgs n. 198/2006) and also to those belonging to Protected Categories (L.68/99).
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