Associate / Senior Associate Quality Assurance Associate French, German, Dutch
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.
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.
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.
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.
* Support the implementation, maintenance and operations of the Quality systems for the Global Business Solutions center.
* Support and manage GMP compliance, GDP (Good Distribution Practice) and Product Complaint 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.
Key Elements Of The Role
* Quality System Activities: Responsible to support the SOP system, GMP record retention system, product quality Personnel Qualification activities, Deviation & Change Control system, Quality Plan, Quality Manual, Recall activities and Product Complaints management process.
* Compliance Activities: Support compliance with any applicable Global Quality Standard & with the Quality Agreement in place between Global Business Solutions Cork/Medical Information & Affiliates.
* 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.
* Quality Activities within IT solution for GBS: Support the Quality Management activities within SAP – QM Power users & QM Data Steward activities.
* Communication Activities: Act as a Quality Contact and active communicator within the Global Business Solutions Center, communicate with the affiliate/QA colleagues and responsible complaints personnel.
* Create, Promote and Maintain Operational Excellence: Actively work in partnership with various cross-functional stakeholders to maintain effective relationships and ensuring efficient and compliant processes.
Requirements
* Degree in scientific disciplines such as Pharmacy, Chemistry, Biochemistry, Microbiology or other relevant Pharma experience positions.
* 2 to 5 years experience within Quality Assurance, Supplier Quality, Regulatory, Medical Information, Laboratory, Supply Chain or other Quality related roles within Pharma.
* Fluency in English, French, Dutch, and German is essential.
* 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. 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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