Expert Specialist-Quality/Complaint

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 Eli Lilly on Our Journey to make an impact on patients' lives
As an Expert Specialist - Quality/Complaint you will
ensure that Product Complaints are handled in compliance with local and global requirements and other relevant complaints documents/SOPs.
Key Essential Functions

• 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.

Quality Unit

• 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.

Responsibilities As Backup Person For Responsible Person In GDP

• Delegated Duties: Keep appropriate records of any delegated duties.
• 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.

Technical Skills

• Scientific background (Pharmacy degree)
• Strong GDP GMP System knowledge
• Familiarity with computer systems
• Decree No. 39/2004 (IV. 26.) ESZCSM and Decree No. 53/2004 (VI. 2.) ESzCsM compliance with the requirements for Responsible Persons

Soft Skills

• Analytical skills
• Assertive Communication
• Flexibility
• Attention to details
• Teamwork

Languages:
English fluent

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