Quality Assurance - Computer Systems at Eli Lilly and Company

Lebanon, Indiana, United States

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Manufacturing, HealthcareIndustries

Requirements

Bachelor’s degree in computer science, Engineering, Life Sciences, or a technology-related field OR 10+ years of relevant experience
3+ years of experience in Automation/QC Labs/IT, Quality, or computer system validation in the pharmaceutical industry

Responsibilities

Establish and maintain CSQ support and sustainability processes
Understand customer, company, and Quality priorities, and support implementation goals
Provide linkages to partner organizations with CSV including Automation/Engineering, Site Equipment Verification, Business QA, and other CSQA persons
Mentor others in CSQA / CSV-related roles
Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the LP1 facility
Provide cross-functional technical leadership in the event of serious quality-related issues with computer systems
Monitor current state of inspection-readiness
Escalate issues appropriately
Promote common process and best practice across functions
Identify systemic issues and trends across functions and drive improvement activity
Understand the external environment/best practices and bring external learning back to Lilly

Skills

Computer System Validation

CSQ

GMP

API Manufacturing

Automation

QC Labs

Regulatory Compliance

Validation Strategies

Inspection Readiness

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.

Land your dream remote job 3x faster with AI

Try Jobo Free