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Role: Sr. Validation Lead

Location: Seattle, WA

Duration:12+ Months



Job Description:

Minimum 9+ years



Primary Skill Set

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.


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Reference : Sr.Validation Lead jobs

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Published at 11-02-2021
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