- Novo Nordisk (Bloomington, IN)
- …Essential Functions + Perform or leading risk assessments + Execute continued process validation and annual product review reports + Support tech transfers of new ... products + Support and review process and engineering validation work + Investigate deviations + Speak with clients,...pharmaceutical products + Knowledgeable in technical guidance documents from FDA , EMA, PDA, ISPE, ICH, ISO, PIC/S and other… more
- Novo Nordisk (Bloomington, IN)
- …equipment + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance ... with FDA GMP requirements + Identify improvements and efficiencies of...and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for established… more
- Lilly (Indianapolis, IN)
- …strategy for packaging. + Experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) regulations, will be vital in ensuring ... + Familiarity with industry standards such as GS1 and FDA DSCSA regulations, System integration with enterprise resource planning...and equipment + 2+ years experience in GMPs and computer systems validation (CSV) Additional Information: +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in Indianapolis. This role will conduct method development and method validation along with day-to-day activities to support commercialization of aseptically ... Support and perform testing for microbial test method development, qualification and validation for bioburden, sterility, and endotoxin testing + Support review and… more
- Sumitomo Pharma (Indianapolis, IN)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Lilly (Indianapolis, IN)
- …Technologist (MT) role in the ELCDL is responsible for specimen handling ( validation , triaging, storage) and analysis of human biological samples using different ... and applying regulations as they relate to analytical method development, validation , and execution. + Conduct and document all laboratory procedures according… more
- Lilly (Indianapolis, IN)
- …and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. **This is a hybrid ... of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA , ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables… more
- Trane Technologies (Noblesville, IN)
- …or more of the following: . Unit preparation . Unit start up procedures and validation . Unit shut down procedures and validation . Wiring and electrical ... needed. Ensure that device history records are completed according to FDA GMP requirements. Complete nonconformance records according to established procedures and… more
- Novo Nordisk (Bloomington, IN)
- …assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems ... oversight of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of the… more
- Cardinal Health (Indianapolis, IN)
- … validation , and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed. + Performs ... of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. + Has experience in authoring… more