- Lilly (Lebanon, IN)
- …and implement the necessary systems and business processes required to support cGMP operations, and build the site culture. This will require significant ... creativity and resilience as the site grows to a full-scale cGMP manufacturing through start up. **Key** **Responsibilities:** **Startup Phase:** + Support… more
- Lilly (Indianapolis, IN)
- …process improvement of existing manufacturing methods via Current Good Manufacturing Practices ( cGMP ). + Produce radioisotopes and drug products following cGMP ... + Maintain accurate and complete lab data notebooks as per cGLP and/or cGMP , as appropriate. + Adhere to all applicable procedures, cGLP, cGMPs, company policies… more
- Novo Nordisk (Bloomington, IN)
- …contact for key customers + Manages QA resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, ... and approval of deviation investigations and change controls pertaining to CGMP production and testing + Supports the establishment, preparation, and communication… more
- Novo Nordisk (Bloomington, IN)
- …in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, ... in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank… more
- Lilly (Indianapolis, IN)
- …IT capability + Compliance + Provide leadership in the development and execution of cGMP and/or improvement plans within the IT function and in support of site ... cGMP improvement plans + Define and execute IT inspection...regulated science-based industry + Regulatory compliance knowledge and experience ( cGMP ) **Additional Preferences:** + Experience in Pharmaceutical assembly… more
- Lilly (Lebanon, IN)
- …compliance with quality systems and current Good Manufacturing Practices ( cGMP ). This oversight includes supporting drug substance manufacturing, central utilities, ... biology, chemistry, computer science, etc.) + Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.). **Additional… more
- Lilly (Lebanon, IN)
- …comply with safety rules and closely following approved procedures to ensure cGMP compliance. + Document all work by following Good Documentation Practices. + ... compliance with safety rules and closely following approved procedures for ensuring cGMP compliance. **Basic Qualifications:** + 480 Volt switch gear + High school… more
- Lilly (Indianapolis, IN)
- …serve as a Site / Plant agent to manage compliance to all cGMP procedures, policies, and guidelines; support issue resolution, and approve recommendations related to ... reliable supply of quality medicine, strong quality culture, and maintenance of cGMP compliance and inspection readiness + Participate actively on the plant lead… more
- Kedplasma (Indianapolis, IN)
- …reactions. Operates within the scope Good Manufacturing Practice and FDA cGMP 21CFR. **JOB SUMMARY** Responsible for performing donor medical qualifications, ... of EU Guidance on Good Manufacturing Practices and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been...in accordance with SOPs, the FDA, OSHA, CLIA and cGMP and company policies as well as educational experience.… more
- Lilly (Lebanon, IN)
- …in STEM Discipline (chemistry preferred) and at least 5 years of experience in cGMP manufacturing OR Master's Degree and 3 years experience in cGMP ... in small molecule, peptide, or oligonucleotide API Manufacturing in a cGMP manufacturing environment. + Proven ability to work within cross-functional Process… more