API Automation & IT Systems Lead (GxP Compliance)

Novo Nordisk

West Lebanon (IN)

Presencial

USD 110.000 - 160.000

Jornada completa

Hace 7 días

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Descripción de la vacante

Novo Nordisk is seeking an IT systems professional to independently manage assigned API automation and IT systems throughout their lifecycle. The role covers development, operation, maintenance, validation, and retirement, with emphasis on GxP compliance, data protection and security controls.

Responsibilities include coordinating validation, leading risk assessments, and maintaining documentation. Ideal candidates have 5+ years in IT systems management in pharma and strong problem-solving and

Formación

Bachelor's degree in IT or related field with 5+ years of IT systems management experience (GxP preferred).
Experience supporting automation/IT systems and batch processes a plus.
Strong problem solving and communication skills; proven regulatory audit experience.

Responsabilidades

Manage lifecycle of assigned IT systems including validation, operation, maintenance and retirement.
Coordinate validation and testing (IQ/OQ/PQ) to demonstrate requirements are met.
Lead risk assessments and change control for assigned systems.
Maintain system documentation, configurations and baselines.
Provide user training and support, manage access reviews and security controls.
Prepare system records for audits and inspections.