- Lilly (Indianapolis, IN)
- …IT support to end-users and addressing their needs promptly. + Maintain computer system validation for responsible applications. + Deliver recommendations to ... time-sensitive situations. **Basic Requirements:** + Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related field. +… more
- Lilly (Indianapolis, IN)
- …related to packaging processes and equipment + 2+ years experience in GMPs and computer systems validation (CSV) + Experience in serialization and full track and ... with stakeholders + Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP, SAP+) and… more
- Sumitomo Pharma (Indianapolis, IN)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Sumitomo Pharma (Indianapolis, IN)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Lilly (Indianapolis, IN)
- …key business partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. Portfolio Delivery + ... of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA , ICH, GCP, PhRMA, Privacy knowledge, etc.) to study database building… more
- Cook Medical (Bloomington, IN)
- …and test method development (design for manufacturing/assembly, process validation , process capability, lean manufacturing, equipment selection and qualification, ... the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable...+ Proven problem-solving skills and High self-motivation. + Good computer skills including knowledge of Microsoft(R) Office. + Organizational… more
- Lilly (Indianapolis, IN)
- …processes and equipment + 1+ years of experience in GMPs and computer systems validation (CSV) **Additional Skills/Preferences:** + Experience in serialization ... with stakeholders + Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP, SAP+) and… more