- ThermoFisher Scientific (Indianapolis, IN)
- … of critical business systems . + Coordinate all aspects of the company's Computer System Validation ( CSV ) and global IT activities supporting ... committed to computer systems compliance and validation.... + Integrate Risk Management tools into a compliant Computer System and Automation Validation … more
- J&J Family of Companies (Anasco, PR)
- …& multi-functional Collaboration** + Lead small to medium-sized multidisciplinary teams including Computer System Validation ( CSV ) specialists, IT ... Procedures (SOPs), work instructions, and user documentation + Manage Computer System Validation ( CSV...systems + Experience with qualification protocols (IQ/OQ/PQ) and validation documentation + Knowledge of 21 CFR Part 11… more
- Endo International (Rochester, MI)
- …The Quality Engineer is a role within the Quality Control organization which oversees Computer System Validation ( CSV ) activities for all Quality ... and deviations + Ensure compliance to data integrity requirements in a GMP environment + Computer System Validation ( CSV ) experience within the life… more
- J&J Family of Companies (Anasco, PR)
- …& multi-functional Collaboration** + Lead small to medium-sized multidisciplinary teams including Computer System Validation ( CSV ) specialists, IT ... Procedures (SOPs), work instructions, and user documentation + Manage Computer System Validation ( CSV...systems + Experience with qualification protocols (IQ/OQ/PQ) and validation documentation + Knowledge of 21 CFR Part 11… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Team, this role involves overseeing the Global Development Quality Vault, ensuring robust Computer System Validation ( CSV ) and quality oversight ... the Quality Management System Framework, Quality Vault, Computer System Validation ( CSV...+ Can assign super-users and SMEs for Quality Vault systems and lead operational and quality metrics development. +… more
- Vera Therapeutics (Brisbane, CA)
- …gathering, configuration, testing, and deployment. * Partner with QA to develop and maintain Computer System Validation ( CSV ) documentation per GAMP5 and ... Systems and will be responsible for leading the implementation, validation , and support of GxP-regulated systems to enable Quality, Regulatory,… more
- J&J Family of Companies (Wilson, NC)
- …support, laboratory equipment lifecycle management including Analytical Instrument Qualification (AIQ) and Computer System Validation ( CSV ), among ... support, laboratory equipment lifecycle management - including analytical instrument qualification, systems and/or CSV support coordination. + Deep understanding… more
- Lilly (Indianapolis, IN)
- …with customers, company, and quality priorities to support implementation objectives. + Participates in computer system validation ( CSV ), computer ... particularly those related to APIs. **Responsibilities:** The Electronic Laboratory Systems Advisor/Sr. Advisor oversees the implementation, validation , and… more
- Lilly (Indianapolis, IN)
- …serialization strategy for packaging. + Experience with Good Manufacturing Practices (GMP) and Computer System Validation ( CSV ) regulations, will be ... Engineer - GSP (Global Serialization Program) for Serialization Execution System (SES) solutions in our Packaging lines, you will...and equipment + 2+ years experience in GMPs and computer systems validation ( CSV… more
- Lilly (Branchburg, NJ)
- …Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation ( CSV ). + Proven ability to ... data including data released from CM (Contract Manufacturers), stability, process validation , and reference standard characterization. + Utilizes technical skills to… more
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