Visual Inspection Subject Matter Expert- Parenteral Products at Eli Lilly and Company

Indianapolis, Indiana, United States

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$144,000 – $211,200Compensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

In-depth technical knowledge of visual inspection processes for parenteral pharmaceutical products
Strong analytical and problem-solving skills
Commitment to product quality and patient safety
Experience with risk-based inspection strategies
Knowledge of FDA regulations and GMP requirements
Ability to develop and deliver training programs

Responsibilities

Lead the design, development, and implementation of visual inspection standards for parenteral products
Evaluate and validate visual inspection processes (manual and automated)
Establish risk-based inspection strategies
Harmonize visual inspection control strategies across internal and external manufacturing networks
Serve as the go-to expert on visual inspection processes and quality standards
Conduct root cause analyses and implement CAPAs
Collaborate with cross-functional teams (QA, manufacturing, engineering, TSMS)
Identify and implement process improvements
Develop and deliver training programs for quality inspectors, operators, and staff
Mentor junior staff and develop training materials
Ensure compliance with FDA and global regulatory requirements

Skills

Key technologies and capabilities for this role

Visual InspectionParenteral ProductsRisk-Based InspectionFDA RegulationsGMPTraining ProgramsProcess ValidationRegulatory ComplianceAnalytical SkillsProblem-Solving

Questions & Answers

Common questions about this position

What is the salary range for this Visual Inspection SME role?

The salary range is $144,000 - $211,200, with actual compensation depending on the candidate’s education, experience, skills, and geographic location.

Is this position remote or onsite?

This is an onsite position.

What key skills are required for this Visual Inspection SME role?

Required skills include in-depth technical knowledge of visual inspection processes for parenteral products, strong analytical and problem-solving skills, experience with risk-based inspection strategies, knowledge of FDA regulations and GMP, and ability to develop training programs.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, with employees working to discover life-changing medicines, improve disease management, and give back through philanthropy and volunteerism.

What makes a strong candidate for this Visual Inspection SME position?

A strong candidate will have in-depth technical knowledge of visual inspection for parenteral products, strong analytical skills, experience with risk-based strategies, regulatory knowledge, and the ability to lead training and harmonize processes across networks.

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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