Computer Systems Validation Jobs in South Plainfield
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Search Results - Computer Systems Validation Jobs in South Plainfield
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), 35 mi from South Plainfield
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
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, 19 mi from South Plainfield
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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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-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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Katalyst Healthcares & Life Sciences-South Plainfield
for lab instruments.
Prepare validation plan and summary reports.
Collaborate with business team for completion of GxP activities as per project plan
What are the top skills required for this role?
Life Sciences Domain knowledge
Computer System...
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Katalyst Healthcares & Life Sciences-South Plainfield
Specific Job Responsibilities
Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing...
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