- Lilly (Indianapolis, IN)
- …with CMs. Provide on-site support during inspections. + Participate on the Technical Review Board + Evaluate and disposition Dry and packaging Product batches, if ... Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to … more
- Lilly (Lebanon, IN)
- …stakeholders. + Support authoring and revision of standard operating procedures and batch records as required. Review technical reports. Conduct ... chillers, cooling towers, compressed air, distillation, tank transfer operation, batch processes, truck/rail operations) + Demonstrated operational capability with… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …+ Provide expert technical oversight of upstream manufacturing operations at CDMOs, including review of batch records , deviation investigations, and change ... of upstream process changes and improvements post-approval. + Author and/or review technical reports, protocols, risk assessments, and relevant sections of… more
- Bristol Myers Squibb (Indianapolis, IN)
- …documentation (eg, protocols, reports, validation activities, specifications, analytical methods, batch records , etc.) that support development, process ... manufacturing facility + Responsible for content development, compilation, maintenance, and review of the facility DMF and/or authoring the facility-based Quality… more
- Novo Nordisk (Bloomington, IN)
- …corrected vision + Abillity to pass color vision test + Ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in ... + Ability to add, subtract, multiply, divide and to record , balance, and check results for accuracy + Ability...and check results for accuracy + Ability to peer review data to ensure data is well organized with… more
- Cardinal Health (Indianapolis, IN)
- …hands-on execution of manufacturing procedures, following standard operating procedures (SOPs), master batch records (MBRs), and protocols. + Lead and/or support ... all production equipment, including clean rooms and isolators. + Record and maintain systems regarding cGMP compliance such as...other status protected by federal, state or local law._ _To read and review this privacy notice click_ here… more
- Lilly (Lebanon, IN)
- …relate to the activities of the TS/MS group. Reviews and approves manufacturing batch records and other manufacturing documentation. + Works with Process Team ... creating real-world solutions. The successful candidate should have a proven track record of driving technical and manufacturing agendas in small molecule. **Key… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …+ Provide expert technical oversight of downstream manufacturing operations at CDMOs, including review of batch records , deviation investigations, and change ... of downstream process changes and improvements post-approval. + Author and/or review technical reports, protocols, risk assessments, and relevant sections of… more
- Lilly (Indianapolis, IN)
- …+ Identify opportunities for continuous improvement in productivity and compliance. + Review GMP documents, including batch records and logbooks. ... providing quality support for the production of sterile CT parenteral drug products review as well as support of commissioning and qualification activities for a new… more
- Novo Nordisk (Bloomington, IN)
- …supporting CGMP programs, including the review and approval of project-specific batch records , procedures, protocols, and reports + Manages the oversight, ... review and approval of deviation investigations and change controls pertaining to CGMP production and testing + Supports the establishment, preparation, and… more