d) at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Experience as a Qualified Person (QP) in certifying and releasing batches of medicinal products
In-depth knowledge of GMP, marketing authorizations, defined procedures, and current regulations
Ability to confirm batches for clinical trials and approve batch certificates
Capability to decide on actions in case of non-compliance
Continuous updating of knowledge on technical, regulatory, and scientific developments
Familiarity with regulatory dossiers, quality contracts, and imported products/active substances
Expertise in corporate standards, new regulations, procedural documents, LIMS, SAP, change management, audits, stability strategies, and visual inspection strategies

Responsibilities

Certify and release batches of finished products, ensuring compliance with GMP, marketing authorizations, procedures, and regulations
Confirm batches intended for clinical trials
Approve batch certificates
Decide on necessary actions in cases of non-compliance
Ensure periodic monitoring of quality review activity for semi-finished products
Stay informed of technical, regulatory, and scientific developments
Consult regulatory dossiers and quality contracts for product batches; participate in contract updates
Ensure documented oversight of imported products and active substances
Analyze corporate standards and participate in their site implementation
Participate in implementing new regulations
Act as approver/reviewer of procedural documents related to QP activities
Approve regulatory specifications of manufactured products in LIMS
Approve in SAP the list of countries registered for finished product codes
Act as reviewer for Annual Product Review (APR), ensuring quality of analysis and conclusions
Conduct impact analyses in the change management system
Verify application of the quality system via audits
Responsible for annual stability strategy and visual inspection strategy on site
Approve stability protocols
Represent Quality Assurance at monthly CCRC Committee
Communicate with subsidiaries/other sites regarding quarantine decisions for shipped batches
Prepare ANIRs (Additional New Information Reports) as part of Annual Reassessment

Skills

Qualified Person (QP)

Batch Certification

Medicinal Product Release

GMP

Pharmaceutical Manufacturing

Quality Assurance

Batch Testing

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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