- 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 (Indianapolis, IN)
- …medicines needed for clinical trials (CT). The CT Active Pharmaceutical Ingredient ( API ) team is responsible for the oversight of CT manufacturing executed ... provides oversight and executes batch release processes for all API used for clinical trials. The API ...including deviations, changes, procedures, and training. + Ensure a self- inspection program is in place and participate in internal… more
- Lilly (Indianapolis, IN)
- …oversight of API EM stability program. + Participate in regulatory inspection preparations with CMs. + Ensure that documented checks have been completed for ... energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization ( API -EM) that delivers a diverse portfolio of medicines essential to our… more
- Lilly (Indianapolis, IN)
- …the world. **Position Description:** This Associate Vice President Quality - Global API / Dry Product Network will provide leadership and compliance support to all ... External Manufacturing for API and Dry Product production. They will have responsibility...Partner with the sites to maintain a state of inspection readiness + Ensure coordination and preparation of pre-approval… more
- Lilly (Lebanon, IN)
- …_Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest ... 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 (Lebanon, 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