d) - 12 month Fixed Term Contract at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Ability to function as a CSQA working with Global Facility Delivery, Lilly project staff, Global CSQA, and External Contracting firms
Knowledge of Quality by Design (QbD) and Quality Risk Management (QRM) principles
Capability to interact with global, project, and functional areas to coordinate design and startup activities
Technical expertise to review and approve project computer system documents for compliance with Lilly Global Quality Standards, project, and local quality procedures
Ability to manage CSQA priorities and schedules for timely delivery of objectives
Experience assisting Data Integrity (DI) related projects
Proficiency in participating in Audit Trail Review of Computer Systems per Global Lilly Standards
Skills in DI Assessment of Computer Systems, Interfaces, and Processes to identify data vulnerabilities
Ability to support site organization in building technical capability, including mentoring new staff
Capability to foster a strong quality culture through open communications, teamwork, and employee participation
Partnership-building skills with Technology Team, system owners, and business owners, providing rationale based on data, Lilly guidance, and priorities
Ability to resolve or escalate compliance issues
Support for QA Compliance team in site readiness plan execution, focusing on startup and ongoing quality oversight
Participation in self-led inspections and support during internal/external regulatory inspections
Ability to effectively review and/or redline documents to ensure quality attributes

Responsibilities

Complete detailed design of assigned areas employing QbD and QRM principles, ensuring integration of Global Quality System requirements
Coordinate design and startup activities to support project and site schedule; consult with Network and Global quality groups for consistent, compliant approach
Assure computer systems (IT systems, Lab Automation, M&Q Automation) at Lilly Alzey site are developed, deployed, and maintained per Lilly standards, Quality Procedures, and regulatory expectations
Provide quality oversight throughout the lifecycle of computer systems to ensure validation state
Review and approve IT/Automation systems related documents according to Risk Evaluation and Responsibilities for Computerized Systems
Assist Data Integrity (DI) related projects for the Alzey site
Participate in Audit Trail Review of Computer Systems and adhere to Global Lilly Standards
Participate in DI Assessment of Computer Systems, Interfaces, Processes to identify potential data vulnerabilities
Support site organization in building technical capability for Quality, project team, and area process teams, including mentoring new staff
Foster strong quality culture, maintaining open communications, promoting teamwork, and employee participation
Establish partnership with Technology Team, system owners, business owners, providing rationale with data/Lilly guidance/priorities
Resolve or escalate compliance issues to project, site, and Quality Management
Support QA Compliance team and site in execution of site readiness plan, focusing on startup and ongoing quality oversight of Computer Systems
Participate in self-led inspections and provide support during internal/external regulatory inspections

Skills

CSQA

Quality by Design

QbD

Quality Risk Management

QRM

Data Integrity

Global Quality System

Computer System Validation

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