• Tempo indeterminato
  • Lombardia
Ruolo

Accountabilities

  • To support the review of design and technical system documentation in relation to company and plant IT projects with GxP impact
  • To guarantee the execution and / or coordination of validation activities and periodic reviews of computerized systems and IT / OT infrastructure
  • To oversee the GxP System Risk Assessment liaising with project and system stakeholder
  • To manage the CAPA management process
  • To oversee validation strategies and the management of GxP system lifecycle documentation, including planning, requirements and system design documents, Testing Protocols, System release documents and maintenance documents (e.g. Change Control, Periodic Review, Incident Management, etc.) in accordance to GAMP5 and internal SOPs
  • To manage and reviews QA documents, SOPs, related to CSV/IT with a focus on GXP
  • To support internal audits (data integrity)
Profilo

Professional Background and Experience

  • Bachelor Degree in Computer Science, Engineering,  Life Sciences/Biomedical matters or Scientific Area
  • At least 5 year of experience as CSV Specialist in Life Science/Health industry

Knowledge

  • English, good
  • MS Office package
  • CSV regulations and guidelines (21CFR part 11, Annex 11, GAMP5) Pharma processes and GxP regulations (mainly GCP, GVP)
  • Risk management principles
  • ISO/IEC 27001:2013 and of ISO 9001:2015
  • Computer information applicable regulation Sito Web / E-mail

Per candidarti invia i tuoi dati a elisa.pizzoli@arithmostech.com