<品質保証部 Quality Assurance> アジアパシフィック品質情報センター Asia-Pacific Regional Center for Product Complaint (APRC) / 担当 Associate / 神戸本社 at Eli Lilly and Company

Kobe, Hyogo, Japan

Eli Lilly and Company Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries

Requirements

  • Full-time employment
  • Ability to serve as a subject matter expert (SME) for applicable systems, procedures, and work instructions
  • Ability to act as an instructor
  • Compliance with Lilly Global/Local Quality Systems and Global/Local regulations

Responsibilities

  • Open and receive returned complaint samples and prepare them for analysis
  • Perform visual and/or functional analysis of returned complaint samples
  • Assess sample analysis results, including complaint level, categories, investigation site, and additional investigation needs
  • Assign and forward complaint samples to designated manufacturing or packaging sites for further investigation as needed
  • Handle import, export, and/or destruction of complaint samples following required procedures
  • Maintain complaint products and lab supplies
  • Conduct cleaning and maintenance of laboratory and equipment
  • Assess product complaint information, including designating complaint levels and categories
  • Determine need for additional investigation and forward records to appropriate manufacturing or packaging quality units
  • Determine the need for investigation of product complaint samples
  • Build and maintain relationships with manufacturing/packaging sites to ensure timely complaint investigations
  • Obtain additional details on complaints from affiliates or related contacts as necessary
  • Evaluate completed investigation results and identify possible root causes
  • Obtain supplementary information from related parties to aid root cause determination when needed
  • Communicate with affiliates or contacts, including educational information during follow-ups
  • Document assessment and analysis results in the complaint database and associated records
  • Review records for completeness and compliance with Global Quality Standards
  • Work effectively as a team to deliver results within defined timelines and manage operations
  • Participate in supporting/supplemental activities, improvement activities, and oversight/monitoring activities
  • Maintain related IT systems

Skills

Sample Analysis
Visual Inspection
Functional Analysis
Complaint Assessment
Laboratory Maintenance
Equipment Maintenance
Import Procedures
Export Procedures
Sample Destruction
Quality Assurance

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.
Potential construction delays in Indiana could affect GLP-1 drug production timelines.
Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.
Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.
FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.
Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.
Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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