- Lilly (Indianapolis, IN)
- …GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional regulatory teams, are ... releases_ + Set appropriatedirection with Global Marketing and GBD teamfordevelopment, review , and approval of promotional claims. + Partner with Regulatory Product… more
- Lilly (Indianapolis, IN)
- …and documents accurate laboratory results which may be subject to regulatory review . + Monitor, operate and troubleshoot instrumentation to ensure functionality. + ... Must follow laboratory procedures. + Demonstrate proficiency and competency. + Document all corrective actions when testing deviates from lab established performance… more
- Lilly (Indianapolis, IN)
- …to identify and mitigate technical and patient risks + Design Reviews: Conduct detailed review sessions with OEMs and project teams to ensure design aligns with all ... Performance Improvements: Identify opportunities to optimize equipment + Safety Risks: Assess, document and engage in HSE walkdowns + Maintenance Plan: Work with OEM… more
- Lilly (Indianapolis, IN)
- …safety. + Computer System Validation Expertise: Data integrity, document deliverables, qualification/validationand security methods for automated controls systems. ... for the equipment's automated control and electrical systems. + Conduct detailed review sessions: with OEM's and project teams, assuring questions are resolved and… more
- Lilly (Indianapolis, IN)
- …Ensure that an accurate instruction set (tickets & procedures) and process flow document describe the process as performed and the control strategy for the discrete ... in real-time to assess process variability and capability. + Understand, justify and document the state of validation with data that evaluate the capability of the… more
- Lilly (Indianapolis, IN)
- …mold review , maintenance/repair, and refurbishment at contract manufacturer + Document and own change controls related to injection molding **Quality System ... and ensure documentation is developed that supports decisions and changes. + Review and approve validation plans, protocols, and individual mold validation summary… more
- Lilly (Indianapolis, IN)
- …abstracts, etc.) based on clinical trial data + Supports authorship and review of clinical / regulatory documents (eg, protocols, Investigator Brochures, clinical ... as a clinical representative on internal and external teams; participates in development, review , and / or presentation of clinical data in internal and external… more
- Lilly (Indianapolis, IN)
- …new technical priorities. + Key position responsibility is to address and document GMP compliance issues and development /execution of process /cleaning validation ... reviews and act as the primary technical representative in a cross-functional setting on Technical Review Board (TRB ) and /or Deviation Review Board (DRB ). +… more
- Lilly (Indianapolis, IN)
- …and accountable for supporting all HSE Corporate and Site Goals. + Technical review , interpretation and release of data including CoT issuance, stability results and ... approves change controls and deviations. + Reviews and interprets data and document results of analyses and conclusions accurately and thoroughly in summary reports… more
- Lilly (Indianapolis, IN)
- …+ Continuous improvement: Refine threat modeling processes and security review methodologies to enhance organizational security posture. **Key Responsibilities:** + ... + Collaborate with teams to integrate security into design processes + Document security best practices and architectural guidance + Conducting threat modeling,… more