Sr. Associate / Principal Associate - Quality Assurance

<p>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.</p><p></p><p><span>At Eli Lilly Cork, 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 41,000 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</span></p><p><span>work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.</span></p><p><span>Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.</span></p><p><span>Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.</span></p><p><span>Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age &amp; Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.</span></p><p><span>Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!</span></p><p></p><p><b><span>Main Purpose and Objectives of Position:</span></b></p><p>The primary responsibilities of the Quality Assurance Representative are to:</p><ul><li><p>Ensure compliance with the Product Research and Development (PRD) quality system and current cGMPs.</p></li><li><p><span>Work across multiple disciplines across Clinical Supply and Delivery to effectively implement the principles of quality culture.</span></p></li><li><p>Be the first QA contact for the GMP <span>Clinical Supply and Delivery </span>functions at Cork.</p></li><li><p>Contribute to the realization of the Quality Objectives in connection with the GMP activities of PR&amp;D.</p></li><li><p>Perform master label review and Quality approvals.</p></li><li><p>Provide Business Quality Oversight of PD Systems, such as e-CTS, SAP.</p></li><li><p>Maintain the relationship with the US and Elects QA team.</p></li></ul><p></p><p><b><span>Key Responsibilities:</span></b></p><ul><li><p>Provide Quality expertise to multiple PRD functions represented at Cork including DP manufacturing, packaging, labelling, supply management, and systems support. Guide and advise on GMP matters.</p></li><li><p>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 (finished and/or semi-finished).</p></li><li><p>Participate in deviation <span>assessments/investigations/approval</span> related to PR&amp;D Cork activities.</p></li><li><p>Participate in change control <span>assessments/review/approval</span> related to PR&amp;D Cork activities.</p></li><li><p>Conduct self-inspections.</p></li><li><p>Participate into triages and act as the quality representative for issues.</p></li><li><p>Participating in regulatory inspections and ensure audit readiness.</p></li><li><p>Ensure GMP/GDP requirements are met for activities performed.</p></li><li><p>Perform master label review and Quality approvals.</p></li><li><p>Provide quality support to master label processes.</p></li><li><p>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. </p></li><li><p>Serve as a mentor for business area personnel.</p>