Non-Clinical Audit Specialist - Remote

Overview

Santen is a pharmaceutical company specializing in ophthalmic care with a 130-year history. As a global company originating from Japan, it has a presence in over 60 countries, providing various innovative treatments and digital solutions to address social issues related to vision health worldwide.

In Short

• Lead non-clinical audit operations to ensure reliability and improve quality.
• Conduct audits based on GLP standards and reliability criteria.
• Assist the team manager in audit operations and problem-solving.
• Strategically plan and revise audit plans according to departmental activities.
• Ensure independence while conducting audits to enhance quality.
• Propose process reforms for audit quality improvement and efficiency.
• Build external networks through industry activities for organizational strength.
• Evaluate the appropriateness and risks of completed tasks and information.
• Negotiate and coordinate with external/internal departments effectively.
• Support team member development and promote collective operations.

Requirements

• 5+ years of experience in GLP testing or quality assurance/audit.
• Practical experience in GLP testing using animals.
• Bachelor's degree in pharmacy, chemistry, or biology.
• Understanding of Japanese pharmaceutical regulations.
• Business-level English proficiency.

Benefits

• Opportunity to work in a global pharmaceutical company.
• Engagement in innovative healthcare solutions.
• Professional development and training opportunities.
• Collaborative work environment.
• Contribution to improving vision health worldwide.