Limerick, Limerick, Ireland
66 days ago
QC Senior Specialist/ Expert Specialist-Esystems

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.

Organization Overview:

The Senior Specialist/ Expert Specialist-Esystems is a member of the Quality Control Laboratory and is responsible for operational and technical support of the laboratory electronic systems used to perform analytical testing, recording and reporting of analytical test results. The electronic systems include systems such as the laboratory information management system LabVantage, Water’s Empower chromatography system and MODA.

Specifically, during the startup phase of the Limerick site (2024 to 2026) the Specialist-Esystems will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function.


Responsibilities:

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.


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.

 

Key Attributes:

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, prioritisation, and organisational 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 take act. 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 organisation.

Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.

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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