Sr. Associate / Principal Associate - Quality AssuranceAt 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 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're looking for people who are determined to make life better for patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions across various Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
The PRD QA Cork - QA Representative is responsible for ensuring compliance with the Product Research and Development (PRD) quality system and current Good Manufacturing Practices (cGMPs). The role involves providing quality expertise to multiple PRD functions at Cork (Manufacturing, Packaging, Master data, IWRS support, Labels), guiding on GMP matters, participating in deviation assessments, change control, self-inspections, and regulatory inspections. The representative will also maintain relationships with the US and Elects QA teams, support master label approvals, and ensure documentation compliance.
Main Purpose and Objectives of Position: Ensure compliance with the Product Research and Development (PRD) quality system and current cGMPs.Work across multiple disciplines across Clinical Supply and Delivery to effectively implement the principles of quality culture.Be the first QA contact for the GMP Clinical Supply and Delivery functions at Cork.Contribute to the realization of the Quality Objectives in connection with the GMP activities of PR&D.Perform master label review and Quality approvals.Provide Business Quality Oversight of PD Systems, such as e-CTS, SAP.Maintain the relationship with the US and Elects QA team.Key Responsibilities: Provide Quality expertise to multiple PRD functions including DP manufacturing, packaging, labelling, supply management, and systems support. Guide and advise on GMP matters.Update the Quality Associate Director/Senior Director/QPs/RPs of any non-conformity and/or issues that may affect quality and/or integrity of the CT Materials.Participate in deviation assessments/investigations/approval related to PR&D Cork activities.Participate in change control assessments/review/approval related to PR&D Cork activities.Conduct self-inspections.Participate in triages and act as the quality representative for issues.Participate in regulatory inspections and ensure audit readiness.Ensure GMP/GDP requirements are met for activities performed.Perform master label review and Quality approvals.Provide quality support to master label processes.Provide business quality oversight for PD systems, such as e-CTS and SAP. Review and approve system changes, data changes, and validation documents to ensure GMP compliance.Serve as a mentor for business area personnel.Ensure documentation produced is handled and stored in compliance with PRD Quality System.Participate in the training of newcomers to the Cork team.Build a strong relationship with the US and ELECTS QA teams to ensure efficient collaboration and communication.Carry out the activities in accordance with company and site safety and environmental requirements.Ensure that confidential information remains confidential.Make quality culture the foundation of work, ensuring our products are safe and effective to improve patients' lives.Maintain ownership and emphasis on quality, ensuring quality in all daily activities.Demonstrate engagement and employ a quality mindset in all endeavours by proactively identifying quality issues and communicating appropriately.Maintain awareness of quality gaps identified by regulatory agencies and internal audits; influence plans and execute actions.Actively participate in the PR&D Quality System by identifying and reviewing procedures, tools, or any other documents that require QA approval.Educational Requirements: Bachelor's degree in a science-related field.Experience Requirements: Minimum 3-5 years' experience in a GMP regulated environment.Language Requirements: Must speak and write fluent English.Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
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.
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