- Sumitomo Pharma (Indianapolis, IN)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Lilly (Indianapolis, IN)
- …compliance with Lilly policies, local and international regulations, laws, guidance (eg FDA , EMA, ICH, etc.), Good Clinical Practices (GCPs) and corporate integrity ... + Provide technical oversight of third-party organizations throughout the transfer, validation and implementation of immunogenicity and biomarker assays used in… more
- Lilly (Indianapolis, IN)
- …Technologist (MT) role in the ELCDL is responsible for specimen handling ( validation , triaging, storage) and analysis of human biological samples using different ... and applying regulations as they relate to analytical method development, validation , and execution. + Conduct and document all laboratory procedures according… more
- Lilly (Indianapolis, IN)
- …and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. **This is a hybrid ... of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA , ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables… more
- Trane Technologies (Noblesville, IN)
- …or more of the following: . Unit preparation . Unit start up procedures and validation . Unit shut down procedures and validation . Wiring and electrical ... needed. Ensure that device history records are completed according to FDA GMP requirements. Complete nonconformance records according to established procedures and… more
- Novo Nordisk (Bloomington, IN)
- …assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems ... oversight of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of the… more
- Lilly (Indianapolis, IN)
- …document GMP compliance issues and development /execution of process /cleaning validation plans. Therefore, the position requires knowledge of cGMPs, applicable ... manufacturing guidance, and the corporate /industry standards for process /cleaning validation . + Influence and implement the network technical agenda within a… more
- Cytel (Indianapolis, IN)
- …support for CMC-related studies, including formulation development, stability studies, process validation , and analytical method validation . + Collaborate with ... + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want our employees to succeed and… more
- Lilly (Indianapolis, IN)
- …packaging. + Experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) regulations, will be vital in ensuring documented processes and ... + Familiarity with industry standards such as GS1 and FDA DSCSA regulations, System integration with enterprise resource planning...+ 2+ years experience in GMPs and computer systems validation (CSV) Additional Information: + Must be able to… more
- Cardinal Health (Indianapolis, IN)
- …materials, in-process, and product samples. + Executes method verification, validation , and/or transfer protocols, analytical equipment qualification protocols, or ... computer system validation test scripts, as needed. + Performs stability testing...experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. +… more