QC Senior Specialist/ Expert Specialist-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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

BASIC REQUIREMENTS:

• Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology or related discipline, with a minimum of 2 years relevant GMP experience.

ADDITIONAL SKILLS/PREFERENCES:

• Safety first approach to all activities.
• Strong Quality and Data Integrity mindset in a QC environment.
• Proficient in English.
• Experience with Quality Control applications e.g. Lab Vantage, MODA,
  Empower, NuGenesis, and benchtop applications such as DataPro2, SoftMax Pro.

• System administrator for Esystems utilized in the QC laboratory.
• Provides first level end-user support for QCL electronic systems including troubleshooting problems at the application layer within their permission level and escalating as appropriate.
• Works with IT, CSV and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach.
• Knowledgeable of general scientific methods and operation of associated Esystems.
• Configures master data, worksheets, methods and reports (tabular, trend and labels) within the QCL electronic systems in a compliant manner.
• Supports the Authoring of key GMP documents such as GMP standard operating procedures, training materials, test methods creation documents, local qualification documents, etc.
• Coordinates with other team members implementing the electronic systems in an efficient manner.
• Processes and supports QCL Informatics Change Control requests and CAPAs.
• Supports Audit requests relating to QC Esystems in a timely manner.
• Provides application assistance prior to, during and post Regulatory/Partner inspections.
• Supports the collation of QCL and other departmental metrics from the QCL electronic systems.