Eli Lilly and Company

Principal Associate Quality API External Manufacturing

Fegersheim, Grand Est, France

Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries

Position Overview

  • Location Type: Onsite
  • Job Type: Full time
  • Salary: Not Specified

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The PIP (person in plant) API EM Quality Assurance Associate will provide support to all quality activities within a dynamic external manufacturing environment. The PIP position is based in Southern France. The candidate must be within commute distance.

The QA Associate’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. The QA Associate will need to interact daily with a wide variety of people, primarily external partners team members and site management.

Key Objectives/Deliverables

  • Serve as a liaison between CMs and Lilly.
  • Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
  • Escalate quality issues at CMs to Lilly QA management.
  • Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
  • Provide quality oversight of Lilly/APIEM Quality Plans
  • Coordinate and perform QA responsibilities of API shipments.
  • Participate in regulatory inspection preparations with CMs.
  • Provide on-site support during manufacturing events and inspections.
  • Participate on the Technical Review Board
  • Evaluate and disposition API batches, if required.
  • Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
  • Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
  • Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
  • Ensure all processes are in an appropriate state of control.
  • Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
  • Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, and computerized system validations.
  • Participate in APR activities.
  • Participate in projects to improve productivity.
  • Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

Requirements

  • BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
  • Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing and QA.

Additional Preferences

  • Experience in quality support for Drug Substance manufacturing activities.
  • Thorough technical understanding of quality systems and regulatory requirements.
  • Knowledge of pharmaceutical manufacturing operations.
  • Demonstrated coaching and mentoring skills.
  • Experience in root cause analysis.
  • Demonstrated application of statistical skills.
  • Demonstrated strong written and verbal communications skills.
  • Strong attention to detail.
  • Proficiency with computer system applications.
  • Excellent interpersonal skills and networking skills.

Skills

Quality Assurance
cGMP
Regulatory Compliance
API Manufacturing
Quality Oversight
Inspection Preparation
External Manufacturing

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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