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System Validation Professional

1 mese fa


Parma, Emilia-Romagna, Italia Massimi Sistemi S.r.l. A tempo pieno
Computerised System Validation Specialist Job in Parma

We are currently recruiting for a Computerised System Validation specialist position at our internationally renowned client in the Life Sciences sector.

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:
  • 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).
  • 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.

We offer an estimated salary between €45,000 and €60,000 per year, depending on qualifications and experience. As a valued member of our team, you can expect a competitive compensation package that reflects your skills and dedication.

This role is based in Parma, Italy. The successful candidate must be able to commute to our office located in the city center.

We believe in equal opportunities for everyone and we apply fair working conditions and salaries related to assigned responsibilities, skills and personal merit.