- Lilly (Indianapolis, IN)
- …Quality Agreements and MRDs. + Coordinate and perform QA responsibilities for API shipments. + Support regulatory inspection preparations and provide on-site ... people around the world. **Job Overview:** The QA - API provides support to all quality activities including batch...support to all quality activities including batch disposition of API batches at Contract Manufacturing organizations (CMs). The QA… more
- Lilly (Lebanon, IN)
- …is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility ... Engineer is responsible for overseeing the facilities at the Lebanon Plant 1 API Manufacturing site. This role ensures the facility infrastructure and systems are… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Position Description:** The Technician - QC - API conducts collection and precise/prompt testing of GMP laboratory samples. This role ... monitoring, as well as testing compressed air and nitrogen for all API buildings. Responsibilities involve ensuring adherence to current Good Manufacturing Practices… more
- Lilly (Lebanon, IN)
- …Indianapolis. The brand-new facility will utilize the latest technology for API Manufacturing and will include several platforms including Peptides, Small Molecules ... in support of site cGMP improvement plans. + Define and execute IT inspection readiness activities. + Operational Excellence + Ensure IT organization is functionally… more
- Lilly (Indianapolis, IN)
- …site-specific needs while ensuring a high level of audit and inspection readiness. **** **Key Responsibilities** **** **Strategic Leadership & Governance** + ... excellence. + Ensure **governance frameworks** are executed at the site level, maintaining ** inspection and audit readiness** in real time. + Act as a champion for… more
- ADM (Frankfort, IN)
- …correct known deficiencies in assets + Work with SMEs to establish inspection and repair plans, identify relevant damage mechanisms, select appropriate inspection ... develop inspection /maintenance plans for all equipment types + Interpret Inspection Reports and ensure mandatory integrity items are planned and corrected.… more
- Lilly (Indianapolis, IN)
- …Lilly PR&D, external contract manufacturing, and non-sterile drug substance ( API ) manufacturing. **Responsibilities:** + Assess differences in current sterility ... PPN including PR&D, external contract manufacturing, and non-sterile drug substance ( API ) manufacturing. + Engage in providing support during regulatory interactions… more
- Lilly (Indianapolis, IN)
- …Microbiology, external contract manufacturing, and non-sterile drug substance ( API ) manufacturing. **Key Objectives/Deliverables:** + Support Central TS/MS Sterility ... to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide… more
- Lilly (Indianapolis, IN)
- …Pilot Plant, which is focused on producing bulk drug substance ( API ) for clinical trials. **Key Responsibilities:** + Responsible for recruiting, onboarding, ... Bioprocess Pilot Plant and the organization remains in a state of inspection readiness + Ensures GMP compliance with environmental monitoring and campaign… more
- Lilly (Indianapolis, IN)
- …of Insulin or Peptide Purification Active Pharmaceutical Ingredient ( API ) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing ... technical objectives, specific product business plan, and quality objectives. + Inspection Readiness focus through developing and maintaining processes that support… more
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