- Lilly (Indianapolis, IN)
- …procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. + ... packaging. + Understanding of basic requirements of regulatory agencies such as the FDA , DEKRA, and OSHA. + Safety equipment (PPE) and precautions required in the… more
- Cook Medical (Ellettsville, IN)
- …Co -O ps may be involved in projects in the following areas: Process Validation ; Test Method Validation ; Sustaining ; Production ; Continuous Improvement ... - Adhere to the Quality Management System (QMS) and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements - Must maintain… more
- Lilly (Indianapolis, IN)
- …procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. 4. ... + Understanding of basic requirements of regulatory agencies such as the FDA , DEKRA, and OSHA. + Excellent interpersonal, written, and oral communication skills… more
- Lilly (Indianapolis, IN)
- …end-users and addressing their needs promptly. + Maintain computer system validation for responsible applications. + Deliver recommendations to implement improved ... manufacturing processes and compliance with industry-specific regulations, such as FDA guidelines for Good Manufacturing Practices (GMP). + Certification in… more
- Parkview Health (Fort Wayne, IN)
- …all applicable research regulations. + Assist with data collection, validation , and quantitative/qualitative analysis. + Contribute to grant proposals, literature ... human subjects protection. Regulatory Compliance Must remain compliant with the following: + FDA Code of Federal Regulations + HHS regulations + ICH Guidelines +… 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
- Eliassen Group (Indianapolis, IN)
- …main focal point for the component system, including data collection, data validation , meeting coordination, rollout execution, and progress updates + Perform risk ... actions + Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components **Experience Requirements:** + Ability to… more
- Ricoh Americas Corporation (Indianapolis, IN)
- …the equipment necessary to validate product quality. + Ensures compliance with FDA , HIPAA, and other applicable regulations. + Develops, recommends, and implements ... 21 CFR 820 required + Prior experience with medical qualification and validation protocols for equipment, systems, processes and products strongly preferred Prior… more