CSV Lead Consultant

Jersey City, New Jersey

Tekfortune Inc
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Role : CSV CONSULTANT
Location : Remote
Duration : Long Term

Mandatory skills : CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools JIRA

Primary Skill- Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management
Secondary Skill- JIRA Veeva Argus Agile and Waterfall methodology
10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document process Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology

Date Posted: 10 May 2025
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