Logo of Huzzle

Intern the Otsuka Way: Inspection Readiness - Otsuka Summer 2024 Intern

Applications are closed

  • Internship
    Full-time
    Summer Internship
  • Business, Operations & Strategy
  • United States
    Remote

Requirements

  • Knowledge of Quality Document Management and the process flow (Quality Docs, EDMS)
  • Experience hosting or participating in GVP partner audits and regulatory inspections
  • Knowledge of GVP, GCP, & GLP global regulations as they relate to Clinical Development, Drug Safety and Drug Development
  • Understanding of being risk based focused and prioritizing work based on Risk Management methodologies
  • Detail-oriented with experience in Quality / Compliance functions
  • Advanced computer skills, including knowledge of working with SharePoint Online, MS Teams, Smartsheet and Tableau
  • Excellent communication skills, both written and oral. Ability to effectively present information to all levels of the organization worldwide and across affiliates
  • Work in a team matrix environment and independently interact with various levels of senior management
  • Educational Qualifications:
  • Minimum:
  • Enrolled in an accredited college or university following the potential internship or co-op assignment
  • Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility
  • Demonstrate ability to work in a team environment
  • Demonstrate ability to think creatively to solve complex problems
  • Exhibits eagerness to learn and ability to learn quickly

Responsibilities

  • Developing and maintaining a comprehensive inspection readiness program, sustainable for increasing inspections across GxP and a wide range of regulatory authorities
  • Integrating cross-functional stakeholder organizations into the inspection readiness
  • Responsible for compiling and reporting of inspection compliance metrics at appropriate levels of management review
  • Maintain inspection readiness artifacts including but not limited to: Inspection Distribution List; Inspection Presentations; Inspection Organization Chart; Inspection Training
  • Help administratively facilitate inspection management response process
  • Monitor the Otsuka portfolio and perform risk assessment regarding the need of Inspection Readiness activities

Creating new products for better health worldwide.

Manufacturing & Electronics
Industry
1001-5000
Employees

Mission & Purpose

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.