Logo of Huzzle

Home

Matches

Explore

Manage

QC Senior Specialist/ Expert Specialist-Esystems

image

Lilly

15d ago

  • Job
    Full-time
    Junior Level
  • Science
  • Limerick

AI generated summary

  • You need a B.Sc. in Chemistry, Microbiology, IT, or related field, 2+ years GMP experience, safety focus, strong quality mindset, proficiency in English, and familiarity with QC applications.
  • You will manage QC electronic systems, provide user support, configure data, assist in GMP document creation, coordinate changes, support audits, and compile departmental metrics.

Requirements

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

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.

FAQs

What is the job title for this position?

The job title is QC Senior Specialist/Expert Specialist-Esystems.

What are the primary responsibilities of this role?

The primary responsibilities include serving as the system administrator for electronic systems in the QC laboratory, providing end-user support, configuring master data and reports, authoring GMP documents, and supporting audit requests, among others.

What qualifications are required for this position?

A minimum of an Honours Degree (B.Sc.) in Chemistry, Microbiology, Information Technology, or a related discipline, along with at least 2 years of relevant GMP experience, is required.

What specific electronic systems will the specialist be working with?

The specialist will work with electronic systems such as LabVantage, Water’s Empower chromatography system, and MODA.

Is experience with Quality Control applications necessary for this job?

Yes, experience with Quality Control applications such as LabVantage, MODA, Empower, and other relevant applications is preferred.

What key attributes are desired for candidates applying for this position?

Desired key attributes include business knowledge, learning agility and curiosity, positive influence, relationship-building abilities, and strong communication skills.

Will the role require working collaboratively with other departments?

Yes, the role involves coordinating with IT, CSV, and Quality departments to ensure the successful implementation of electronic systems.

Are there opportunities for professional development in this position?

Yes, the role offers opportunities for continuous learning and professional development, as indicated by the emphasis on self-management and feedback seeking.

Does Lilly offer accommodation for applicants with disabilities?

Yes, Lilly is dedicated to helping individuals with disabilities actively engage in the workforce and provides a process to request accommodations during the application process.

How does Lilly approach diversity and inclusion in hiring?

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.

Lilly

We're a medicine company turning science into healing to make life better for people around the world.

Manufacturing & Electronics
Industry
10,001+
Employees
1876
Founded Year

Mission & Purpose

Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.