Computer Systems Validation Jobs in New Jersey
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Search Results - Computer Systems Validation Jobs in New Jersey
Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Possess hands-on experience with the Veeva Vault QualityDocs System.
Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration...
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Staffing Statistics-Allendale (NJ)
and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.
• Experience with application system validation and infrastructure qualification.
• Experience with vendor audit for computer...
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Katalyst Healthcares & Life Sciences-South Plainfield
Description: Seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant!
Together...
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Daiichi Sankyo, Inc.-Trenton
centered around rare diseases and immune disorders.
Summary
Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems are compliant...
2 similar jobs: Newark, Jersey City
Katalyst Healthcares & Life Sciences-Columbia (NJ)
Responsibilities and Requirements:
Must be from Life science or Pharma domain experience.
He should be capable of managing 10+ members team.
7+ years of total IT experience out of which 5+ years of experience in Computer Systems. Validation...
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3 similar jobs: Irvington, South Plainfield, Springfield
Bridgewater (NJ)
and select CS+T supplier(s), and ensure effective onboarding and implementation (e.g., qualification, Computer System Validation (CSV), system specifications, UAT).
• Responsible for oversight of the CS+T vendors (e.g., IRT/RTSM, eCOA/ePRO) and ensuring both...
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The Dignify Solutions, LLC-Jersey City
with the project team to ensure compliance with regulations, policies, standards, procedures, and associated documentation including but not limited to computer systems validation, SOX, and PM standards
Ensure all projects adhere to project methodology compliance...
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Piscataway
with LIMS GTech Lead to implement and manage LIMS Master Data Data Governance policies
• Partner with Quality on documentation required for FDA Part 11 Computer System Validation
• Manage Digital Library platform, budget, vendor relationships, contracts...
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Katalyst Healthcares & Life Sciences-South Plainfield
Computer Systems Validation)
Knowledge of CSA (Computer system Assurance).
Work with business users to understand the business requirements from a testing standpoint for a project.
Define / Implement / Track Test Strategy for each application...
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The Dignify Solutions, LLC-Jersey City
documentation including but not limited to computer systems validation, SOX, and PM standards
Continually update relevant business stakeholders of project status and periodically publish project status reports
Assist, share learning, and mentor others within...
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Katalyst Healthcares & Life Sciences-South Plainfield
Job Description
The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin business...
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Katalyst Healthcares & Life Sciences-Princeton (NJ)
Responsibilities and Requirements:
Computer System Validation in addition to validation and regulation experience, the resource should have the following
Experience: 3-7 years of relevant experience; can work independently and guide mentor Junior...
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Katalyst Healthcares & Life Sciences-Raritan (NJ)
Responsibilities:
Computer System Validation =>Supporting and Validating Regulatory systems like REMS RIMS.
Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Business...
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Katalyst Healthcares & Life Sciences-South Plainfield
to identified user needs.
Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts.
Executes and facilitates GxP Computer System Validation activities...
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Katalyst Healthcares & Life Sciences-South Plainfield
Duties/Responsibilities
• Provide independent technical leadership and accountability for overall computer system validation efforts.
• Ensure quality and compliance in accordance with established procedures and standards of the Quality Systems...
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