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