Validation Lead/Manager
Company: Cognizant
Location: Rockville
Posted on: November 19, 2022
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Job Description:
Validation Lead/Manager Location: Rockville, MD or Princeton, NJ
Job Description: Application Skills: Argus, TrackWise and other
R&D GxP systems Documentum or any document management system
such as EDMS, MicroFocus ALM (Test Management Tool) Mandatory
Domain Knowledge: 10 years of Experience in Life Sciences, Computer
System Validation Pharmacovigilance knowledge Must possess hands on
experience and understanding of: GAMP 5 Risk Based Validation
Functional Risk Assessment GXP Assessment 21 CFR Part 11 Assessment
Data Migration Qualification Disaster Recovery Qualification
Qualification and Commission Validation coverage in IQ, OQ and PQ
Deviation management process CAPA Validation Summary Reports
Knowledge on Infrastructure IQ & qualification Leading and managing
testing and validation activities in synchronization with project
scope, schedule and objective Possess formal training/certification
on Testing & Validation Excellent communication skills Excellent
technical writing skills Should be able to work independently with
minimum supervision Should have worked in cross-functional
environments and comfortable to liaison with business/Clients
Technical Skills: R&D GxP system validation experience,
Knowledge on systems like EDMS, TrackWise, GAMP 5 Risk Based
Validation, Functional Risk Assessment, GXP Assessment, 21 CFR Part
11 Assessment, Data Migration Qualification, Qualification and
De-Commission, Validation coverage in IQ, OQ and PQ, Deviation
management process, CAPA, Validation Summary Reports
Keywords: Cognizant, Rockville , Validation Lead/Manager, Executive , Rockville, Maryland
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