About Lilly:
We unite caring with discovery to make life better for people around the world. As a global healthcare leader, we are headquartered in Indianapolis, Indiana. Our employees worldwide 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 put people first and strive to give our best effort to our work.
Job Summary:
We're looking for a determined individual to join our team as a Lead Specialist QC Esystems in the Limerick Quality Control Laboratory (QCL). This role will provide technical support for the electronic systems within the laboratory, ensuring compliance and operational support of all testing activities within the QCL function.
Main Responsibilities:
* Serve as a key technical SME on QCL electronic systems, including but not limited to LIMS and Empower.
* Provide guidance to the laboratory on the configuration and optimal use of Esystems.
* Troubleshoot complex problems at the application layer within permission level and escalate as appropriate.
* Configure master data, worksheets, methods, and reports within QCL electronic systems.
* Author/review key GMP documents such as standard operating procedures, training materials, test methods creation documents, and local qualification documents.
* Train other team members on core QC Esystems.
* Coordinate across business departments and stakeholders to implement enhancement requests for QCL electronic systems.
* Process and support QCL Esystems Change Control requests.
Requirements:
* Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology or related discipline, with a minimum of 6 years relevant GMP experience.
* Strong Quality and Data Integrity mindset in a QC environment with excellent attention to detail.
* Proficient in English.
* Technical expertise in Quality Control applications, e.g., Lab Vantage, MODA, Empower, NuGenesis, and benchtop applications such as DataPro2, SoftMax Pro.
* Highly competent in the use of digital solutions for data, equipment, and laboratory management.
* Experience with regulatory inspections.
Key Attributes:
* High performance in delivery of their work with self-management, prioritisation, and organisational skills.
* High learning agility and flexibility with ability to deal with ambiguity and uncertainty.
* Demonstrated ability to address issues and take actions, trusted by the team to follow through.
* Ability to establish and maintain key relationships across all levels in the organisation.
* Demonstrated ability to influence peers and across functions.
* Strong communication skills, written and oral in 1:1 and group situations.
* Decisive decision-making with ability to collate required information and ask questions of peers.