- Lilly (Indianapolis, IN)
- …serialization strategy for packaging. + Experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) regulations, will be vital in ... + Familiarity with industry standards such as GS1 and FDA DSCSA regulations, System integration with enterprise...and equipment + 2+ years experience in GMPs and computer systems validation (CSV) **Additional… more
- Lilly (Indianapolis, IN)
- … validation activities. + Assess, qualify, and validate equipment, critical systems (utilities), facilities, computer system , cleaning, manufacturing, and ... project teams and represent validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts… more
- Novo Nordisk (Bloomington, IN)
- …+ Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution + ... audit observations and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for… more
- Novo Nordisk (Bloomington, IN)
- …Draft, review, execute, and approve protocols and summary reports related to Automation System Validation (CSV).. + Review and approve changes to computerized ... + Technical Requirements: + Ability to use Excel, Word, and other office systems + Strong understanding of cGMP regulations, FDA guidelines, and industry… more
- Novo Nordisk (Bloomington, IN)
- …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality ... systems requirements. This includes systems implementation and...of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of… more
- Lilly (Indianapolis, IN)
- …maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) ... the latest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...direction and standards. + Experience leading or supporting the Computer System Validation of IT… more
- Lilly (Indianapolis, IN)
- …centralized management of validation activities in alignment with Lilly Computer System Validation (CSV) policies for systems in the PA Integration ... maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) and other… more
- Lilly (Indianapolis, IN)
- …meet quality and compliance standards. Experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) regulations will be vital in ... environment and manage multiple tasks simultaneously. + Experience with Computer System Validation . + Familiarity...+ Familiarity with industry standards such as GS1 and FDA DSCSA regulations + System integration with… more
- Lilly (Indianapolis, IN)
- …and mentorship in the execution of change controls, equipment qualification, process validation , computer system quality, deviations, and complaint ... Processes, Quality Systems , and FDA regulations + Experience supporting computer systems (eg CSV, CSQ, IDS experience) + Proficiency with computer… more
- Novo Nordisk (Bloomington, IN)
- …through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and ... for routine testing + Supports instrument onboarding and maintenance + Method Validation + Accountable for daily operations to maintain Quality standards and project… more