Lead Specialist QC Esystems

at  Lilly

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.

BASIC REQUIREMENTS:

• Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology or related discipline, with a minimum of 6 years relevant GMP experience.

ADDITIONAL SKILLS/PREFERENCES:

• Safety first approach to all activities.
• Strong Quality and Data Integrity mindset in a QC environment. 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 Technical SME on the QCL electronic systems including but not limited to LIMS and Empower.
• Very knowledgeable of general scientific methods in the laboratory and the Esystems that support the laboratory.
• Works with global functions in the development and delivery of standardized processes and procedures for the electronic systems in QCL.
• Primary contact for IT, CSV and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach.
• Provides guidance to the laboratory on the configuration and optimal use of Esystems.
• Provides end-user support for QCL electronic systems including troubleshooting complex problems at the application layer within their permission level and escalating as appropriate.
• Configures master data, worksheets, methods and reports (tabular, trend and labels) within the QCL electronic systems.
• Supports the Authoring/review of key GMP documents such as GMP standard operating procedures, training materials, test methods creation documents, local qualification documents, lab/ equipment/ computer system periodic reviews, annual product reviews, validation master plans etc.
• Trains other team members on core QC Esystems.
• Coordinates across business departments and stakeholders, gathering, and supporting the implementation of enhancement requests for the QCL electronic systems.
• Processes and supports QCL Esystems Change Control requests.
• Identifies and implements appropriate CAPAs for the QCL Esystems.
• Leads Audit requests relating to QCL Esystems.
• Support the collation of QCL and other departmental metrics from the QCL Esystems.