Quality Assurance Associate

As Quality Assurance Associate you will support the Quality Team in activities for oversight of Eli Lilly products distributed within the United Kingdom and Republic of Ireland through the implementation of an Affiliate Quality System. You will align with both UK and IE regulations and Lilly quality expectations to ensure product quality, patient safety and customer satisfaction. Scope Of The Role The scope of the role includes all GDP related operations within the UK and IE Affiliate and third parties authorised by Eli Lilly to store and distribute Lilly products. Product quality complaints for human health medicines from UK & IE customers, health care professionals, external parties and sales representatives. Key Responsibilities Product Complaints:

• Provide support for the Responsible Complaints Person (RCP) and backup RCP to ensure there is a local procedure for product complaints in place that meets Regulatory and Corporate requirements, and that this procedure is on the Learning Plan of all personnel involved in handling product complaints. The procedure should include:
• Receipt of complaints
• Receipt of samples
• Adding complaints to the Global Complaints database, TrackWise
• Handling and shipment of samples to investigation sites
• Closing complaint investigations and replying to complainants where appropriate
• Reconciliation of complaints
Work with the European Regional Centre to manage complaints and relationships between the groupsMaintain relationships and communication with Global Patient SafetyPrepare metrics and complaint summary reports in accordance with local proceduresReview complaints closed after the 45-day target with local managementProvide knowledge and support to the Medical Information team in Cork and other RCPs as required. Other Responsibilities
• Support other members of the Quality Team in ensuring the UK and IE Affiliate complies with CQP-181
• Support activities related to the Affiliate Quality Plan and team actions
• Ensuring documents are generated, controlled and retained in accordance with site SOPs which meet Lilly Global Quality Standards
• Take a proactive role in leading Team projects to improve and innovate current practices.
  
  B.Sc in the science degree
• Strong attention to detail
• Analytical mindset
• Ability to demonstrate resilience
• Effective communication- written and oralStrong learning agility
  
  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., Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.