- PACIV (Indianapolis, IN)
- …to completion action items for any deficiencies resulting from Periodic Reviews. + Update Computer System Validation ( CSV ) documentation which may ... environment. This role is responsible for executing and managing periodic reviews of computer systems , and driving resulting action items to completion.. The… more
- PACIV (Indianapolis, IN)
- …testing protocols, and final reports. + Proficient in Commissioning & Qualification (C&Q) and/or Computer System Validation ( CSV ), with a solid ... and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments. Join our Indianapolis, IN team… more
- Lilly (Indianapolis, IN)
- …that their assigned functional areas, projects and/or systems comply with corporate computer system validation ( CSV ) standards. This includes ... Systems Standards, Practices, and Procedures, providing oversight for CSV execution (including approving CSV documents per...and supplier assessment activities to ensure the state of computer system validation is clearly… more
- Lilly (Indianapolis, IN)
- …facilitate remediation efforts. + Influence and oversee the Commissioning and Qualification (C&Q) and Computer System Validation ( CSV ) of GMP assets ... is responsible for the Quality oversight of FUME and computer systems regarding system development...FUME processes, and Computer System Validation principles. + Become/remain certified on CSV … more
- Lilly (Indianapolis, IN)
- …efforts, including hypercare support and frontline troubleshooting. + Ensure compliance with Computer System Validation ( CSV ) standards, including ... is ideal for someone who is passionate about technology, systems thinking, and supporting frontline manufacturing teams. **What You'll...or packaging operations. + Working knowledge of cGMP and Computer System Validation ( CSV… more
- Cardinal Health (Indianapolis, IN)
- …+ Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation ( CSV ) methodologies. + Define technical ... You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team… more
- Lilly (Indianapolis, IN)
- …Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation ( CSV ). + Proven ability to ... and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical skills to lead or… more
- Lilly (Indianapolis, IN)
- …efforts. + Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems + Validation ( CSV ) of GMP assets including review and ... in a cGMP facility + Prior experience in C&Q, CSQ, and/or CSV + Proficient with computer systems including Microsoft Office, electronic document management … more
- Lilly (Lebanon, IN)
- … Plan. * Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: + Process ... for both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum BS… more
- Cardinal Health (Indianapolis, IN)
- …Protection Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/ CSV ( Computer System Validation ), DSCSA(Drug ... products company. We provide customized solutions for hospitals, healthcare systems , pharmacies, ambulatory surgery centers, clinical laboratories, physician offices… more