GxP Systems and Support Administrator

Added
18 days ago
Type
Full time
Salary
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Related skills

data integrity gxp eqms eu annex 11 cmms
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๐Ÿ“‹ Description

  • Administer GxP applications and supporting infrastructure, including eQMS, CMMS, and digital
  • Manage user accounts, role-based access controls, SSO and SCIM integrations, periodic access
  • Configure systems and coordinate upgrades, patches, and other technical changes through established
  • Deploy and manage project-based instances of digital validation applications to support
  • Support Computer Software Assurance activities by reviewing vendor testing packages, performing
  • Create, review, and support the approval of validation documentation, SOPs, work instructions

๐ŸŽฏ Requirements

  • A bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field
  • At least 3โ€“5 years of experience administering IT systems and providing technical support is
  • Demonstrated experience supporting validated computer systems throughout their full lifecycle, with
  • Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity, and Good
  • Experience working with Information Security and Quality teams to ensure technology environments
  • Proven experience with change management, investigations, deviations, CAPA-related activities, and

๐ŸŽ Benefits

  • Base salary range of $130,000โ€“$150,000 per year, excluding benefits.
  • Comprehensive health insurance coverage.
  • 24 days of paid time off.
  • Company-paid life insurance.
  • Company-paid long-term disability coverage.
  • Remote work arrangement.
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