- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to...validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and requirements for validationDevelop and implement strategies for equipment IQ/OQ/PQ, process validation , computer system validation and ... and subject matter experts to prepare for FDA and other agency auditsEnsure site/ system validation program meets FDA, ISO and EU requirementsCollaborate with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …11 requirements, FDA regulated environments, industry practices on computer validation , and Sarbox regulatory requirements of computerized systems Moderate ... of a hybrid in-office working environment. Qualifications A Bachelor's degree in Computer Science, Information Systems , Business Administration or other related… more
- Catalent (St. Petersburg, FL)
- …years total relevant experience will be considered.Pharmaceutical and/or life sciences experience including Computer System Validation , 21 CFR Part 11 and ... could include all or some aspects of the Quality function.The RoleEnforce Computerized System Validation (CSV) guidelines, policies, and procedures for control … more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control, Client interface, Lab… more
- Catalent (St. Petersburg, FL)
- …Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems ; b) process improvement projects and Product Development ... QA Product Manager Position SummaryThe QA Product Manager ...has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.The QA… more
- Aequor (Libertyville, IL)
- …experience in building all layers of IT infrastructureMust have GMP and computer systems validation experience in pharmaceutical manufacturing5&plus years ... with global standards. Additionally, Client will be implementing technology solutions and systems as part of multi-year IT roadmap to support business growth as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, ... to achieve-Site Ready.Participates & provides inputs on site selection and validation activities.Performs remote and on-site monitoring & oversight activities using… more
- Eisai, Inc (Nutley, NJ)
- …vendors, and consulting companies); Managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP policies. ... Architects and IT Operations. Partner with ITQA, Business Owner and IT Project Manager for defining a master validation strategy where applicable. Partner with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager throughout all phases of ... achieve Site Ready.Participates & provides inputs on site selection and validation activities.Performs remote and on-site monitoring & oversight activities using… more
- Merck & Co. (Rahway, NJ)
- …Development, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, Systems Integration, TestingPreferred Skills:Business Administration, ... with other tools, technologies, security controls, governance processes, and compliance validation .Develop a library of deployable and documented design patterns and… more
- Novo Nordisk Inc. (Durham, NC)
- …approval of validation activities associated with minor changes to existing systems . Performs archiving duties & QA presence & process confirmation on shop ... floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with...Understanding of the Batch Review Processes required Understanding of validation preferred Understanding of quality management systems … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …incident escalation and follow-up beyond the organization, Tier 4) Analyze complex computer systems , identify problems, and develop and implement logical ... IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems : Drive...including close interaction with other local SMEs in IT/OT, System Managers, and IT QA Maintain IT services and… more
- Colorado Housing and Finance Authority (CO)
- …for Single Family loans daily. Performs assignments out of Mortgage Electronic Registration System (MERS) on all loans in a delinquency and bankruptcy status and ... provides backup to MERS system . Monitor the advance and repayment of funds advanced...there are any issues. This individual reports to the Manager of Servicing and Post Closing. essential functions *… more
- Rees Scientific Corporati (Chicago, IL)
- … Manager Payroll Type: Salary FLSA Status: Non-Exempt Job Summary:As a System Validation Specialist, you have hands on experience with installing, ... repairing, calibrating, and inspecting monitoring equipment used in healthcare facilities. The System Validation Specialist will maintain a local stock of… more
- MAHLE, Inc (Lockport, NY)
- …level. Willingness to travel and technical support on site. Keeping the Project Manager and Product System Development Team Leader informed about the progress ... SUMMARYThe Electrical Systems Development Engineer is responsible for coordinating the engineering domains (Requirements Management, Hardware, Software, Mechanics,… more
- Bering Straits Native Corporation (Jamestown, ND)
- …James town, North Dakota.The Lab is under construction. The Project Engineer Lab Manager will participate in the certification and validation through the ... Corporation is currently seeking a qualified project Engineer Data Manager for the United State Army Corp of Engineers,...computer screens and requires extensive use of a computer , keyboard, mouse, and multi-line telephone system .… more
- Doosan Bobcat (Moorhead, MN)
- …to strategic objectives.Job Requirement Education Required: Bachelor's Degree in Computer Science, Management, Information Systems , Software Engineering, ... Job InformationThe Digital Business Product Manager will drive the company's digital product and service portfolio by working with our technical, engineering,… more
- Doosan Bobcat (Minneapolis, MN)
- …to strategic objectives.Job Requirement Education Required: Bachelor's Degree in Computer Science, Management, Information Systems , Software Engineering, ... Job InformationThe Digital Business Product Manager will drive the company's digital product and service portfolio by working with our technical, engineering,… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …hire date)Educational Requirements: Bachelor's Degree, preferably in a related field ( Computer Science, Business Analytics, Management Information Systems , Data ... Job Category:Information Technology Work Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is rooted in a foundation of improving the health of… more
