- ThermoFisher Scientific (Indianapolis, IN)
- …manufacturing equipment. Quality Assurance: Support quality assurance activities, including process validation , equipment qualification, and root cause analysis. ... contributing to the development and optimization of manufacturing processes for pharmaceutical products. Key Responsibilities: Process Improvement: Assist in the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …support OPDC R&D products; including LIMS data, method development & validation , method transfers and testing (release, stability). + Maintains KPIs/quality metrics ... related Science. + Four years of combined experience in pharmaceutical /medical device industry as a manager in Manufacturing, QA...Thorough understanding of GMP requirements and the Drug Development process . + Knowledge of FDA 21 CFR Parts 210… more
- Sumitomo Pharma (Indianapolis, IN)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... + Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support)… more
- Lilly (Indianapolis, IN)
- …end-users and addressing their needs promptly. + Maintain computer system validation for responsible applications. + Deliver recommendations to implement improved ... senior management. **What You Should Bring:** + Deep understanding of pharmaceutical operations, especially in manufacturing, supply chain, and compliance. +… more
- Lilly (Lebanon, IN)
- … variability and capability. + Understand, justify and document the state of validation ( process and cleaning) with data that evaluate the capability of ... manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and… more
- Roche (Indianapolis, IN)
- …+ Manages multiple projects and time scopes for each project. + Ensures process changes are characterized and implemented following validation policies and ... required by the production schedule. You will troubleshoot equipment and process issues, lead/contribute to process improvement/characterization projects, train… more
- Lilly (Indianapolis, IN)
- …the world. **Organization Overview:** Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a ... with a wide variety of people, primarily external partners, process team members and site management. The candidate will...resolve/escalate. + Understand, justify and document the state of validation with data that evaluate the capability of the… more
- Lilly (Lebanon, IN)
- …support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and ... a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process … more
- Roche (Indianapolis, IN)
- …+ Manages multiple projects and time scopes for each project. + Ensures process changes are characterized and implemented following validation policies and ... required by the production schedule. You will troubleshoot equipment and process issues, lead/contribute to process improvement/characterization projects, train… more
- Lilly (Indianapolis, IN)
- …may be required to support business needs. + Previous equipment qualification and process validation experience. + Previous experience with deviation and change ... + **Technical Excellence:** Lead and provide technical and effective process support services for production issue resolution and investigations, ensuring… more
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