Principal Scientist - Quality Control Compliance
Locations:
Ireland, Limerick
Time Type:
Full time
Posted on:
Posted 30+ Days Ago
Job Requisition ID:
R-62058
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.This facility will be Lilly's most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance.
This is a unique opportunity to be a part of the technical team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the technical capabilities to enable a successful startup of c GMP manufacturing operations.
The Senior Scientist Compliance role in Quality Control provides technical support for the compliance systems within the quality control laboratory.
This role will be responsible for the interpretation of regulations; design, implementation, compliance and support of the laboratory quality systems associated with all testing activities within the QCL function.
Specifically, during the startup phase of the Limerick site (2024 to 2026), the senior scientist compliance will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function.
Interpret regulatory requirements and global quality standards to develop and maintain local paper free, digital enabled systems, processes and procedures.
Own the GMP readiness plan for the labs to ensure a consistent and compliant approach across all laboratories during start up.
Design, implement, maintain and own the analytical equipment lifecycle management process including oversight of third-party service providers providing support for equipment lifecycle activities.
Review GMP documents associated with equipment qualification and calibration including DQ/IQ/OQ/PQ documents for analytical equipment and associated utilities.Implement the QCL Training / Personnel Qualification Strategy for start-up and subsequent phases ensuring alignment with site policies and procedures.
Serve as QC SME for lab processes such as equipment qualification, lab investigations, personnel qualification etc.Author/review key GMP documents such as GMP standard operating procedures, training materials, test methods, qualification documents, lab/ equipment/ computer system periodic reviews, annual product reviews, validation master plans etc.
Process owner for lab specific GMP service providers.Support and participate in self-inspection or other audits with particular reference to the analytical aspects of c GMPs as defined by the Health Authorities, and Food and Drug Administration.
Collate QC compliance metrics and make recommendations to management on actions.in Analytical Chemistry, Chemistry / Biochemistry, Microbiology, Molecular Biology, or related discipline, with a minimum of 5 years relevant GMP experience.