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.
Organization Overview:
Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
Main Purpose and Objectives of Position:
We are seeking highly motivated, talented Quality Assurance Associates to support our new Biologics Manufacturing Facility. The ideal candidate is an organised and a methodical professional who fosters a positive team environment.
Provides Quality leadership, direction and governance for materials management.
Assures consistent implementation of Quality standards across the quality system for materials management.
Manages quality-related matters specific to Materials.
Is responsible for approving appropriate quality-related documents.
Performs ongoing monitoring that includes:
monitoring of quality systems,
the self-inspection program,
verification of the effective implementation of key GMP programs, and
review of systems that impact Product Quality to ensure that they operate in a state of control.
Establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.
Continue to provide coaching and mentoring to operations personnel and to other QA reps, on the appropriate risk management to provide appropriate and timely solutions to compliance in a business focused fashion.
Key Responsibilities:
Develop and implement Quality system for materials management including, SOPS, Quality agreements and Risk assessments.
Review and approval of change controls, observations deviations, intra company issues associated with the area(s) of responsibility.
Reports & escalates critical quality issues to the appropriate level of quality management.
Review and approval of other key GMP documents such as GMP standard operating procedures, sampling protocols, receiving instructions,
Understand the Monitoring and Maintenance of all aspects of GMP compliance.
Participate in quality risk management activities such as FMEA’s.
Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility
Communication and education of personnel in GMP requirements and Contribution to the GMP Plan for Materials Management.
Assess the impact on product quality of issues associated with materials and consumables.
Assurance that the Quality System(s)/Program remains in a validated state and within regulatory commitments.
Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program.
Support slow moving inventory and product discontinuation initiatives.
Liaison between process team and other quality areas.
Benchmarking of current and emerging Materials Management initiatives.
Ensure the required relevant knowledge and experience/training necessary to fulfil duties is acquired.
Basic Requirements:
BSc (Hons) in Science, Engineering or Quality related discipline with appropriate experience.
Additional Skills/Preferences:
Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritization, and organizational skills.
Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.
Positive Influence: Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organization.
Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
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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