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 Quality systems & specific requirements from Affiliates as part of the routine operations
Ensure Quality coverage to the Supply Chain activities & interactions between Lilly Service Providers & Affiliates
Support and Manage the Quality oversight of the Inventory Management systems ie. Expiration & retest monitoring, returns, destruction and adjustment of inventories.
Help, give guidance and problem solve on resolution of complex Quality issues
Anticipates customer needs and handles non-standard requests
Quality Activities within IT solution for GBS
Support the Quality Management activities within SAP – QM Power users & QM Data Steward activities
Support and manage order overrides within SAP where applicable
Support and manage DSP requests
Communication Activities
A Quality Contact and active communicator within the Global Business Solutions Center
Active communication with the affiliate/QA colleagues
Has impact within related departments or areas
GMP Instructor
Communication with Affiliate QA and Regulatory for product destination country
Create, Promote and Maintain Operational Excellence
Actively work in partnership with various cross-functional stakeholders (internally & externally) to maintain effective relationships and ensuring efficient and compliant processes
Ensure the culture of compliance is reinforced continuously within the team
Continuously look for and or lead where possible continuous improvement initiatives including standardization and/or re-engineering of processes and controls
Drive for results and ensure best practices are in place to achieve highest standards within daily operations
Drive cross-functional projects where opportunity arises
Demonstrate excellent project management abilities and strong understanding of financial systems
Support organizational changes
Analyse and translate data into key strategic inputs and insights to drive decision making
Proven ability to work on high level value-add ad hoc projects while continuing to achieve routine goals
Personal Attributes
Ability to handle complexity and utilize analytical skills, with attention to detail and a risk based solution oriented approach
Ability to effectively prioritize and complete key tasks and deliverables whilst also engaging others to achieve their deadlines towards compliance and change initiatives
Ability to communicate effectively and influence across all levels and disciplines of the organisation
Ability to be flexible
Appreciation of cultural diversity
Education
Degree in scientific disciplines such as Pharmacy, Chemistry, Biochemistry, Microbiology or other relevant Pharma experience positions.
Previous Experience
3 to 5 years experience within Quality Assurance, Supplier Quality, Regulatory, Medical Information, Laboratory, Supply Chain, Master Data or Quality related roles within Pharma.
Language Requirement
English
IT Literacy
Proficient in MS Office
Good working knowledge in SAP is an advantage
Trackwise
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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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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