Multilingual Quality Assurance Associate/Senior Associate

Overview

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

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. 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.

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 & 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.

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, Business Operations Medical Information and Order to Cash, Regional Quality and Quality Assurance Associate Director for the GBS’s, 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, GDP (Good Distribution Practice) and Product Complaintactivities 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 (propose actions and action owner)
- Support the Quality Manual
- Support Recall activities ie. local at GBS and Affiliate
- Support Product Complaints management process from receipt and entry into the database system up to responding to the complainant and final close out while keeping the local Responsible Complaint Person (RCP) and Product Quality Representative (PQR) involved in communications.
- Support projects with Quality involvement
- Product Quality instructor /trainer for personnel (GMP Induction and GMP refresher)

Compliance Activities

- Support compliance with any applicable Global Quality Standard & with the Quality Agreement in place between Global Business Solutions Cork/Medical Information & Affiliates ( including maintaining updates)
- Support Audits and Self assessments preparation and observations completion
- Ensure that the regulatory and Quality impact review is done for deviations and Change Control
- For product complaints, ensure follow up if necessary is done in collaboration with Regional Centre for product complaints and Global Security

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 on resolution of complex Quality issues as applicable

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 and responsible complaints personnel
- 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
- Ensure best practices are in place to achieve highest standards within daily operations

Language Skills: Fluency in English is required, along with proficiency in at least one of the following languages: French, Dutch, or German

Education

Degree in scientific disciplines such as Pharmacy, Chemistry, Biochemistry, Microbiology or other relevant Pharma experience positions.

Previous Experience

2 to 5 years experience within Quality Assurance, Supplier Quality, Regulatory, Medical Information, Laboratory, Supply Chain or other Quality related roles within Pharma.

IT Literacy

- Proficient in MS Office
- Good working knowledge in SAP
- Trackwise and One QMS

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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