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.
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
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 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.
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!
The PRD QA Cork - QA Representative is responsible for ensuring compliance with the Product Research and Development (PRD) quality system and current Good Manufacturing Practices (cGMPs). The role involves providing quality expertise to multiple PRD functions at Cork (Manufacturing, Packaging, Master data, IWRS support, Labels), guiding on GMP matters, participating in deviation assessments, change control, self-inspections, and regulatory inspections. The representative will also maintain relationships with the US and Elects QA teams, support master label approvals, and ensure documentation compliance. A Bachelor’s degree in a science-related field and 5 years of experience in a pharmaceutical GMP environment are required

EDUCATIONAL REQUIREMENTS:

• Bachelor’s degree in a science related field

EXPERIENCE REQUIREMENTS:

• Minimum 3-5 years’ experience in a GMP regulated environment.

LANGUAGE REQUIREMENTS:

• Must speak and write fluent English
  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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MAIN PURPOSE AND OBJECTIVES OF POSITION:

The primary responsibilities of the Quality Assurance Representative are to:

• Ensure compliance with the Product Research and Development (PRD) quality system and current cGMPs.
• Work across multiple disciplines across Clinical Supply and Delivery to effectively implement the principles of quality culture.
• Be the first QA contact for the GMP Clinical Supply and Delivery functions at Cork.
• Contribute to the realization of the Quality Objectives in connection with the GMP activities of PR&D.
• Perform master label review and Quality approvals.
• Provide Business Quality Oversight of PD Systems, such as e-CTS, SAP.
• Maintain the relationship with the US and Elects QA team.

KEY RESPONSIBILITIES:

• 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.
• 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).
• Participate in deviation assessments/investigations/approval related to PR&D Cork activities.
• Participate in change control assessments/review/approval related to PR&D Cork activities.
• Conduct self-inspections.
• Participate into triages and act as the quality representative for issues.
• Participating in regulatory inspections and ensure audit readiness.
• Ensure GMP/GDP requirements are met for activities performed.
• Perform master label review and Quality approvals.
• Provide quality support to master label processes.
• 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.
• Serve as a mentor for business area personnel.
• Ensure documentation produced is handled and stored in compliance with PRD Quality System.
• Participate in the training of newcomers to the Cork team.
• Build a strong relationship with the US and ELECTS QA teams to ensure efficient collaboration and communication.
• Carry out the activities in accordance with company and site safety and environmental requirements.
• Ensure that confidential information remains confidential.
• Make quality culture the foundation of work, to ensure our products are safe and effective to improve patients’ lives.
• Maintain ownership and emphasis on quality, ensuring quality in all daily activities.
• Demonstrate engagement and employ a quality mindset in all endeavours by proactively identifying quality issues and communicate appropriately.
• Maintain awareness of quality gaps identified by regulatory agencies and internal audits; influence plans and execute actions.
• Actively participate in the PR&D Quality System by identifying, reviewing of procedures, tools or any other documents that require QA approval.