Computerised System Validation Specialist

4 giorni fa

Ravenna, Emilia-Romagna, Italia Maasi Enterprises Ltd A tempo pieno

Job Summary

We are seeking a highly skilled Computerised System Validation Specialist to join our team at Maasi Enterprises Ltd. As a key member of our organization, you will be responsible for ensuring the validation of computerized systems in the Life Sciences sector.

Main Responsibilities

  • Independently manage the activities of test ideation and execution.
  • Assist clients in software system validation.
  • Draft validation plans, conduct tests, collect and evaluate results, and prepare validation reports.
  • Define and draft validation plans, validation reports, test plans, acceptance criteria, user requirements, etc.
  • Write and review standard operating procedures and work instructions.
  • Prepare technical specification documents (design and functional) in collaboration with process or solution engineers, and manage revisions and approval workflows.
  • Write and execute IQ/OQ/PQ test protocols for computerized systems, processes, equipment, and utilities.
  • Execute technical impact assessments.
  • Write and review calibration and maintenance plans.
  • Write and review 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).
  • 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.

What We Offer

  • Internal and external training programs.
  • Performance bonuses.
  • Overtime pay in accordance with regulations.
  • Team building activities.

Benefits

  • A salary pack that matches your responsibilities.
  • A growth plan.
  • Attractive bonuses on results-based.
  • Internal and external trainings specifically selected on your aptitudes and talent.
  • A set of benefits, services, and affiliations on top of the profession's health insurance.

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