- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems ... Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV… more
- Aequor (San Diego, CA)
- …for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems .Serve as the CSV subject ... Acadia on procedures relating to quality, data integrity and computer system validation .Primary Responsibilities:Responsible for...minimum of 7 to 8 years of experience in computer systems validation in the… more
- Insmed Incorporated (NJ)
- …Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation , Quality Management Systems ProcessesWho ... compliance with FDA, ICH, and EU regulations.Review and approve computer system validation (CSV) deliverables...system lifecycle management activities to ensure that GxP computer systems remain in a validated and… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Validation Execution: Field Execute and oversee… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... landscape and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical,… more
- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for ... development organization, there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy will… more
- Cipla (Hauppauge, NY)
- …(DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the ... to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and… more
- Eisai, Inc (Tampa, FL)
- …skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice...Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… more
- Insmed Incorporated (NJ)
- …years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other ... will include, but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs… more
- Insmed Incorporated (NJ)
- …hands on experience in a validation role with responsibility for computer systems specifically LIMS, Empower, BMRAM, Chromeleon, environmental monitoring ... like change controls, release management, and reviews of validated systems . Author CSV Documents ( Validation Plans and...CSV documents in Veeva Train, coach, and mentor GxP system owners. Who You Are: Position Requirements (Required and/or… more
- Cipla (Fall River, MA)
- …IT Manufacturing, Packaging and WH Systems support including IT administration, Systems Validation , PLC. SAP Skills in Production, WH, Packaging and Quality ... and vendors / partners. This role will perform IT Systems Support including Systems Implementation, Validation...end business processes to have the capability to propose system changes, process transformations in line with the evolving… more
- Merck & Co. (Durham, NC)
- …of regulatory requirements in accordance with GMP manufacturing operations.Proficiency in computer systems and applications including but not limited to:- ... (eg washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)-Automated Systems (eg Distributed Control System (DCS), Programmable Logic… more
- Merck & Co. (Durham, NC)
- …of regulatory requirements in accordance with GMP manufacturing operations.Proficiency in computer systems and applications including but not limited to:- ... washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic… more
- Columbia Technology Partners (Annapolis Junction, MD)
- …, coordinate penetration testing, and provide a comprehensive verification and validation report (certification report) for the information system . Provide ... , coordinate penetration testing, and deliver a comprehensive verification and validation report (certification report) for the information system … more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Cipla (Reid, WI)
- …candidates with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and ... procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site...sense of urgency Excellent computer skills, specifically Microsoft Office Suite. Solid organizational and… more
- Cipla (Fall River, MA)
- …Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc. Technical Knowledge and Computer Systems Skills Understanding of machines used in ... Quality Team. The QA operation specialist (MDI) monitors and ensures validation and qualification of facility, utilities, equipment's, processes and ensure product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment. This role will ensure compliance within the document management system , document storage and retention, and document issuance and reconciliation.Key ... documents to ensure compliance with global and site proceduresSupport Document Management system users with workflow handling and electronic system usageManage… more
- Northrop Grumman (MN)
- …Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations ... making history. Bring your experience to Northrop Grumman Defense Systems in Plymouth, MN . We are seeking an...to 12 engineers responsible for research, design, integration, and validation of Test Equipment and test processes for development… more
- Northrop Grumman (MD)
- …Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations ... our customers. We cover a wide variety expertise within the systems engineering domain. This includes mission engineering, requirements, architecture, modeling and… more
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