PRD QA Engineer

5 days ago


Indianapolis, Indiana, United States Eli Lilly Full time
Job Summary

We are seeking a highly skilled PRD QA Engineer to provide quality oversight of all materials used in clinical trials. The successful candidate will be responsible for ensuring compliance with quality systems and current Good Manufacturing Practices (cGMP).

Key Responsibilities
  • Provide technical guidance and leadership in interactions with business and operations personnel.
  • Consult and interpret local procedures, corporate standards, and regulatory requirements.
  • Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts.
  • Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets.
  • Evaluate potential product quality impact for any GMP-related incident and support investigations.
Requirements
  • Bachelor of Science Degree in Engineering or related field.
  • 3+ years supporting cGMP manufacturing.
  • Demonstrated relevant experience in a cGMP facility.
  • Proficient with computer systems including Microsoft Office and electronic document management systems.
About Eli Lilly

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. We are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs.


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