Associate / Senior Associate - Quality Assurance

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.

About us

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 39,000 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 work, and we put people first. 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 2,000 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.

Lilly 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.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Job description

Roles and Responsibilities include Recognize, exemplify and adhere to the Lilly values which center on our commitment to People, Excellence and Compliance.

This role reports to the Quality Assurance Associate Director for GBS Cork, Kuala Lumpur and Mexico. In collaboration with Affiliates, Order to Cash Operations, Regional Quality and GBS QA Lead you will support the implementation, maintenance and operations of the Quality systems for the Global Business Solutions center.

For the Global Business Solutions Center you will support and manage GMP compliance and GDP (Good Distribution Practice)  activities and GMP decisions on Products and Quality issues in conjunction with the appropriate Affiliate Product Quality Representative, Regional Quality Leader and GBS QA Associate Director.

The Key elements of the role will include:

Quality System Activities

• Responsible to support the SOP system ie. from initiation to review and approval

• Responsible to support the GMP record retention system

• Support the product quality Personnel Qualification activities

• Support the Deviation & Change Control system (inclusive of evaluations, close out, tracking and trending)

• Manage and support the Quality Plan (action owner and final close out)

• Support the Quality Manual

• Support Recall activities ie. local at GBS and Affiliate

• Support Product Complaints management

• Support projects with Quality involvement and may lead small to medium projects or programs with minimal to moderate risks and resource/financial requirements

• Product Quality instructor /trainer for personnel (GMP Induction and GMP refresher)

• Responsible for the Quality Management activities within our ERP system (SAP) associated to Customers and Material Master

Compliance Activities

• Support compliance with any applicable Global Quality Standard & with the Quality Agreement in place between Global Business Solutions Cork & Affiliates ( including maintaining updates)

• Makes decisions within guidelines and policies where appropriate ie. provide support for quality compliance in accordance with the Global Quality Lilly Standards and Health Authority requirements

• Support  Audits and Self assessments preparation and observations completion ( internally at GBS and Affiliate where necessary)

• Ensure that the regulatory and Quality impact review is done for deviations and Change Control

Business Support

• Support the GMP compliance of the SAP activities performed by the Global Business Solutions Center

• Ensure the Global Business Solutions Center is following the appropriate Qualit