Technology Compliance Specialist GxP Manufacturing - amgen

Key Responsibilities

• Ensure compliance with GxP regulations for manufacturing technology systems.
• Develop and execute validation protocols for IT systems used in manufacturing.
• Conduct regular audits and assessments of technology infrastructure and processes.
• Collaborate with cross-functional teams to address compliance gaps and implement corrective actions.
• Maintain documentation related to system validation and compliance activities.
• Support regulatory inspections and inquiries related to manufacturing technology.

Requirements

• Proven experience in GxP regulated environments, specifically within manufacturing.
• Strong understanding of IT system validation principles and methodologies.
• Experience with compliance auditing and risk assessment.
• Excellent documentation and communication skills.
• Ability to work effectively in a team and manage multiple priorities.