Expert Specialist-Quality/Complaint at Eli Lilly and Company

Budapest, Hungary

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Not SpecifiedCompensation

Expert & Leadership (9+ years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Analytical skills
Assertive Communication
Flexibility
Attention to details
Teamwork
English fluent

Responsibilities

Daily management of Product Complaints in accordance with the SOP for handling Product Quality Complaints
Daily management of medical devices involved in Complaints management according to the local SOP for Devices inventory management
Classify and document all locally received PC cases/suspected product defects
Timely translation and forwarding of product complaint reports
Support follow-up requests
Ensure optimal communication related to Product Complaints
Collaborate with the Regional Complaints Team to seek advice, inputs, and guidance on all related Product Complaints matters/projects
Monitor any changes in local regulations with respect to Product Complaints
Function as the local Regulatory Authority contact for Product Complaints issues
Provide training related to Product Complaints
Ensure appropriate link between Product Complaints and Pharmacovigilance
Keep appropriate records of any delegated duties (as Backup Person for Qualified Person)
Ensure the implementation and execution of Lilly Global Quality Standards and local regulations
Monitor regulatory compliance and ensure adherence to EU GDP and GMP standards
Manage supplier relationships and ensure GDP compliance in warehousing and distribution
Prepare for and participate in Health Authority inspections, internal and external audits, and follow up on audit findings
Conduct cold chain assessments and ensure proper handling of temperature-sensitive products
Act as the anti-counterfeiting contact and manage related activities
Maintain a quality management system
Ensure the accuracy and quality of records
Oversee initial and continuous training programs
Coordinate and perform recall operations for medicinal products
Address relevant customer complaints effectively
Approve suppliers and customers
Manage subcontracted activities impacting GDP
Conduct self-inspections at regular intervals and implement corrective measures
Manage product quality-related matters, including decisions on returned, rejected, recalled products, and falsified medicines

Skills

GMP

GDP

Pharmacovigilance

Regulatory Compliance

SOP Management

Product Complaint Handling

Supplier Management

Quality Assurance

EU Regulations

Training Delivery

Health Authority Inspections

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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