- Lilly (Indianapolis, IN)
- …As part of this team, the Manager is responsible for overseeing the review , approval, and maintenance of QS documents, partnering with key business areas, and ... QS Management** + Manage PR&D QS documents through preparation, review , approval, and maintenance processes to meet business and...stakeholders and teams with expertise in PR&D QS and document management processes. + Guide Document Owners,… more
- 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)
- …applications). **Primary Responsibilities:** **1. Content Strategy and Execution: Document Preparation, Development and Finalization/ Document Management** + ... create content strategy for writing projects. + Plan, write, edit, review , coordinate, and complete the regulatory documents supporting clinical development/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)
- …material and components within the scope of the process team including: + Review product demand and develop monthly demand consolidation and forecasts. + Partner ... raw materials for supply requirements. + Lead the inventory target creation, review , and performance of slow-moving obsolete inventory. + Work with internal… 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 (Plainfield, IN)
- …principles to NALO operations, using Lilly quality standards. Author and review and approve Risk Assessments to ensure adequate oversight including external ... service provider per Supplier Quality Management System. + Manage, investigate and document product and distribution complaint and monitor performance. + Author, … more