- 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
- 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 ManagerPosition Summary The QA Product Manager provides customer service, with the highest integrity,...Projects; c) all product process validation and cleaning validation documents; d) all… 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
- Catalent (San Diego, CA)
- …direct experience and working knowledge of validation principles, including validation of processes, equipment, systems , analytical methods, cleaning, and ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego,...and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …position interacts with all levels of Project Managers, Business Analysts, other Systems Analysts, Application Developers, Architects and System Engineers as ... Requirements 0-10% overnight travel required. Qualifications A BS Degree in Computer Science, Information Systems , Business Administration or other related… more
- Merck & Co. (Rahway, NJ)
- …clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity review and reconciliation, ... direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end...least BA or BS degree, preferably in life science, computer science, or health care related discipline. Knowledge and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …& understanding of change control processes Expert understanding of validation / system development life cycle approach Basic computer skills including ... eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering… 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
- Merck & Co. (Durham, NC)
- …refrigeration systems ).Good oral and written communication skills Proficiency in computer systems and applications including but not limited to:- Microsoft ... generation/distribution, reverse osmosis skids, compressed gas systems ) Automated Systems (eg Distributed Control System (DCS), Programmable Logic… more
- Aequor (Seattle, WA)
- …of manufacturing quality (manufacturing, packaging, facilities, critical systems , validation , etc.). Must complete tasks independently, notify manager of ... skills with MS Office (eg Word, Adobe, Visio and Excel) and with Quality Systems (eg Document Management System , Quality Management System ) Must demonstrate… more
- Novo Nordisk Inc. (Durham, NC)
- …or medical device industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred General ... and QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with Regulations, ISO… more
- Cook Medical (Pittsburgh, PA)
- …motivated by helping others, and driven by integrity, we invite you to apply. The Computer System Validation Manager at Cook MyoSite, Inc. manages ... and computer system hardware. The Computer System Validation Manager...for validation approaches to computer systems and IT infrastructure. The information technology manager… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... 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
- Bristol Myers Squibb (Bothell, WA)
- …deliverable in respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex 15 principles and ... reports + Expert knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …quality oversight and support for process, cleaning, shipping, computer system , equipment and instrument qualification and validation activities + ... of validation standards as they apply to facilities, utilities, equipment, computer systems , cleaning and processes. Additionally, person in this role is… more
- CACI International (Houston, TX)
- …integrated Verification and Validation (V&V) of the on-board, autonomous Vehicle Systems Manager (VSM) and Autonomous Systems Management Architecture ... Lunar Gateway Autonomous Control System Verification and Validation Engineer Job...USG facilities. + BS in Electrical, Mechanical, Aerospace, Software, Computer or Systems Engineering, Computer … more
- Microsoft Corporation (Redmond, WA)
- …(such as System on Chip(SoC) FWs, Basic Input Output Systems (BIOS), Baseboard Management Controllers(BMC), Rack Manager etc.). + Collaborate with ... 5+ years of professional experience in validation , design/development, integration, or system level debugging in firmware/embedded systems . + 5+ years of… more
- PCI Pharma Services (Rockford, IL)
- …calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . + Computer Validation Focus: Ability to ... validation plans for new customer / product / system project launch and maintains existing validated processes /... computer tasks and have some experience with computer systems considered to have an impact… more
