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 Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. We are seeking highly motivated, talented Quality Assurance candidate to support our new Biologics Manufacturing Facility. The ideal candidate is an organised and a methodical professional who fosters a positive team environment.

This position is full-time on site in Raheen, Limerick reporting to Associate Director.

Main Purpose and Objectives of Position:

• Provide Quality direction and governance for the specific area of responsibility.

• Manage quality-related matters specific to area of responsibility

• Responsible for approving appropriate quality-related documents.

• Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns.

• Performs ongoing monitoring that includes

- monitoring of quality systems,

- the self-inspection program, time on the floor program

- verification of the effective implementation of key GMP programs

- Review of systems that impact safety, identity, strength, purity, quality to ensure that they operate in a state of control.

• Establishment, maintenance and management of a control system for training of individuals in the specific Quality System and/or Quality Program assigned.

• Provide coaching and mentoring other QA Reps on the appropriate risk management to provide appropriate and timely solutions to compliance in a business focused environment.

The role operates on standard working week. The job may also involve some non-scheduled call-in time to respond to emergencies etc and some scheduled call-in time

Educational requirements: Third level qualification; BSc, M.Sc., or PhD in Biotechnology, Chem, Eng or related discipline with appropriate experience

Key Responsibilities:

• Assures consistent implementation of standards across the quality system.

• Maintenance of all aspects of GMP compliance for the area(s) of responsibility.

• Establishment, maintenance and management of a control system for the specific Quality System(s)/Program.

• Interpretation and application of emerging regulatory & GMP guidelines to the specific Quality System(s)/Program

• Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program.

• Own, review or approve change controls (including implementation steps), deviations (including tasks) associated with Supplier/service provider Management.

• Reports & escalates critical quality issues to the appropriate level of quality management for final resolution.

• Audit and participation in the site self inspection and time on the floor program for the area of responsibility for compliance with GQS & local procedures

• Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in the area of responsibility.

• Evaluation, audit scheduling and approval of 3rd party supplier/service providers/contractors as appropriate for the area of responsibility.

• Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.

• Contribution to the Quality plan for specific quality system/program initiatives.

• Ensure that the required relevant knowledge and experience necessary to fulfil duties is acquired.

• Establishing and Maintaining the supplier/service provider files for the Limerick site

• Generation of supplier files for materials & consumables

• Liaise with QA Procurement and participate in changes

• Participate in network groups to ensure we are continually learning/improving the system and sharing best practices (including supplier/service provider audit forum)

• SME for site Global QS requirements on materials

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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