We are seeking a skilled technical professional to support the Quality Control Laboratory (QCL) in its electronic systems implementation.
About this Role:
* This position will provide technical support for electronic systems within the QCL laboratory, ensuring compliance and operational support of laboratory electronic systems associated with all testing activities.
* The Specialist/Lead will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function during the startup phase of the Limerick site.
Key Responsibilities:
1. Serve as the key technical SME on QCL electronic systems, including but not limited to LIMS and Empower.
2. Work with global functions in the development and delivery of standardized processes and procedures for electronic systems in QCL.
3. Be the primary contact for IT, CSV, and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach.
4. Configure master data, worksheets, methods, and reports within the QCL electronic systems.
5. Support 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.
Requirements:
* Serve as the key technical SME on QCL electronic systems.
* Be very knowledgeable of general scientific methods in the laboratory and the Esystems that support the laboratory.
* Work with global functions in the development and delivery of standardized processes and procedures for electronic systems in QCL.
* Provide guidance to the laboratory on the configuration and optimal use of Esystems.
Benefits:
* Opportunity to work on the implementation of electronic systems within the QCL laboratory.
* Collaborative, inclusive, energetic work environment.
What We Offer:
We strive to put people first and deliver exceptional results in everything we do. 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.