Consultant - Validation at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Passion for shaping the future of validation using modern approaches like AI and automation
Experience or knowledge in IT system operational compliance, regulatory requirements, and Lilly standards/processes
Ability to drive innovation with AI, digital tools, automation, risk-based approaches, and automation frameworks
Skills in evaluating emerging technologies (e.g., AI-assisted authoring, digital validation platforms)
Capability to coordinate compliance activities, apply right-sizing methods, and determine deliverables
Proficiency in reviewing and updating AI/auto-generated validation documents for accuracy and compliance
Strong communication skills to escalate issues, risks, and findings to stakeholders like ISQ
Ability to educate stakeholders on IT operational processes and compliance requirements
Experience collaborating with cross-functional teams to identify, mitigate risks, and provide guidance/training

Responsibilities

Drive innovation in validation by exploring and leveraging AI, digital tools, and automation to streamline validation documentation and operational compliance
Identify opportunities to simplify and automate IT system operational compliance activities using digital tools, AI-enabled solutions, risk-based approaches, and automation frameworks
Continuously evaluate emerging technologies (e.g., AI-assisted authoring, digital validation platforms) and recommend practical use cases for efficiency and quality improvement
Coordinate IT system operational compliance activities and ensure compliance with regulatory requirements and Lilly processes
Apply appropriate right-sizing method/approach and determine the nature and content of deliverables in scope
Oversee AI/auto-generated validation documents by reviewing and updating contents to ensure accuracy, compliance, and alignment with Lilly’s quality management system
Escalate and communicate operational issues, critical compliance findings, and risks to the Information System Quality (ISQ) organization and other key stakeholders
Educate stakeholders (Owner, Custodian) on Lilly IT operational processes and compliance requirements
Collaborate with cross-functional teams to identify and mitigate compliance risks, while providing guidance and training

Skills

CSV

IT Compliance

GxP

Validation

Automation

ERP

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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