IT infrastructure CSV Consultant

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Company: Katalyst HealthCares and Life Sciences

Location: Cranbury, NJ 08512

Description:

Responsibilities:
  • We are seeking a Validation & IT Systems Specialist to join our dynamic team.
  • This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications.
  • IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp.
  • Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment.
  • Manage system configurations, troubleshooting, and maintenance in collaboration with IT teams.
  • Support the software development lifecycle, ensuring alignment with validation and compliance standards.
  • Proven expertise in computer system validation (CSV) and GMP compliance.
Requirements:
  • Overall 10+yrs of experience.
  • Experienced in IT infrastructure CSV Qualifications (Authoring, Executing, and Reviewing the documents.
  • Experienced in IT infrastructure administration functions (Server, Workstations, Backup, Controller, and Windows operating system).
  • Validation Expertise - ensuring compliance with 21 CFR and Good Manufacturing Practice (GMP) standards.
  • IT Administrative Support.

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