IT Systems Validation Specialist

Delan: IT talent hunters 2099-03-04T18:23:01+05:00 2024-05-29
  • Offer # : 4268
  • Region : Ville Saint-Laurent
  • Type of position : Permanent
  • Salary : TO BE DISCUSSED

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About the client

CONFIDENTIAL

Tasks/Responsibilities

The IT Systems Validation Specialist will be responsible for ensuring that the IT infrastructure and systems comply with specific industry standards (Health Canada, FDA, GAMP5, and others).

 

MORE PRECISELY

 

  • Carry out periodic evaluations of the systems to validate them with the applicable regulations
  • Assess risks and impacts, anticipate audits and ensure that everything is done in accordance with standards
  • Prepare and coordinate the validation phases of IT systems and write the documentation
  • Issue strategy recommendations to establish good GxP practices
  • Work closely with two compliance specialists
  • Participate in the evaluation and qualification of IT suppliers

 

 

PROFILE

 

  • 5+ years of IT experience
  • Professional experience in systems validation and/or compliance
  • Knowledge of GAMP5 and FDA standards, especially Title 21 CFR Part 11
  • Spirit of mutual aid and interest in the pharmaceutical sector
  • Knowledge and ease with IT system an asset
  • BAC in computer science or equivalent
  • Bilingualism required (French and English)