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CSV Validation Lead

Company: ValueLabs, Inc.
Location: Eden Prairie
Posted on: February 24, 2021

Job Description:

Role: Validation LeadDuration: Long Term ContractLocation: Seattle, WA Please find the JD: Primary Skill Set --- 5+ years of direct experience with CSV activities preferably with MES system, strong knowledge of GAMP, risk-based approaches to validation and good understanding of electronic records and signatures--- Knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures--- Familiar with development of CSV documentation (Validation Plans, Requirements, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs)--- Familiar with diverse computerized systems: ERP, LIMS, Validation Lifecycle Software, QMS, Learning Management System, Safety Database--- Experience in following CSV methodology for implementing and maintaining Infrastructure (IaaS), Platform (PaaS) and SaaS systems. Roles and Responsibilities --- Author applicable CSV documentation.--- Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.--- Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures.--- Ensure the validation of computerized systems used across GxP operations is conducted in compliance with applicable regulatory requirements and internal procedures. - provided by Dice

Keywords: ValueLabs, Inc., Eden Prairie , CSV Validation Lead, Other , Eden Prairie, Minnesota

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