Computer Systems Validation Jobs in New Jersey
1 - 15 of 21
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...
jobvertise.com -
Katalyst Healthcares & Life Sciences-South Plainfield
for a science and risk-based approach to qualification of systems, equipment, utilities, and/or facilities
• Working knowledge of US FDA CFRs and European EMA, including ICH regulations
• Experience authoring, reviewing, and approving validation documentation...
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Intone Networks-Parsippany
maintaining compliance with all relevant regulations. QualificationsProven experience in computer system validation with a focus on SAP implementation.Strong understanding of GxP requirements and the ability to integrate them into the validation process...
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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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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...
icims.com -
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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Summit (NJ)
with Computer System Validation and expertise with 21 part 11 requirements.Basic Requirements:
• Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.
• Minimum 3-5 years relevant work experience...
pharmiweb.jobs -
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-Warren Grove
SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
BS in Engineering or Science related discipline required.
Minimum 3 years of experience in FDA-regulated industry.
Minimum 3 years...
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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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Katalyst Healthcares & Life Sciences-Raritan (NJ)
Responsibilities & Requirements:
Expert Skills- Computer System Validation.
Validating ERP to AWS Data migration process.
Validating Data migration project.
Experience in the Pharmaceutical, biotechnology, or medical device industry.
5+ years...
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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-South Plainfield
Requirements:
3. 5 years experience as a CSV specialist within the Life Sciences Industry.
1. 2 years experience with ERP validation, SAP S/4 HANA experience preferred.
Knowledgeable in US and Global Computer system Validation requirements.
Knowledge of GAMP...
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TechDigital Corporation-Raritan (NJ)
in Computer System Validation (Based on the role selected)
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Knowledge of FDA guidance's and industry standards (i.e., GAMP)
Experience...
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