Quality Assurance Associate
4 weeks ago
We’re looking for people who are determined to make life better for people around the world.
Main Purpose and Objectives of the Job Role:
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. To comply with both UK and IE regulations and Lilly quality expectations to ensure product quality, patient safety and customer satisfaction.Scope:
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 complaintsReceipt of samplesAdding complaints to the Global Complaints database, TrackWiseHandling and shipment of samples to investigation sitesClosing complaint investigations and replying to complainants where appropriateReconciliation of complaints Work with the European Regional Centre to manage complaints and relationships between the groups Maintain relationships and communication with Global Patient Safety Prepare metrics and complaint summary reports in accordance with local procedures Review complaints closed after the 45-day target with local management Provide knowledge and support to the Medical Information team in Cork and other RCPs as required.Other Responsibilities:
Assess temperature excursions and communicate assessment results to Logistic Service Providers (LSPs) 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.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly
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