Global Computer Systems Quality Assurance Rep

Bengaluru, Karnataka, India

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$60,000 – $80,000Compensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, Information Technology, Quality AssuranceIndustries

Requirements

Candidates should possess a Bachelor’s degree in Computer Science, Information Systems, or a related field, and have at least 5 years of experience in Computer Systems Validation (CSV) within a pharmaceutical or regulated industry. Strong knowledge of corporate Computer System Validation (CSV) standards and practices is essential, along with the ability to interpret and apply these standards to various systems and projects.

Responsibilities

The Computer Systems Quality Assurance Representative will be responsible for ensuring that assigned Functional Areas, Projects, or Systems comply with corporate Computer System Validation (CSV) standards, including providing consulting and interpretation of these standards, overseeing CSV execution, maintaining awareness of relevant standards, and assuring inspection readiness. This role involves maintaining Inspectional Readiness, ensuring supported systems are validated, participating in inspections and audits, tracking quality actions, and providing updates to stakeholders. Additionally, the representative will deliver projects and programs, provide training on CSV-related topics, and partner with Business, Business Quality, and IT customer areas to deliver business value.

Skills

Computer System Validation (CSV)

Pharmaceutical Regulations

Inspection Readiness

Audit Management

Quality Assurance

Training

Project Management

Stakeholder Management

SQL

Data Analysis

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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