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Validation Lead/Manager

Company: Cognizant
Location: Rockville
Posted on: November 19, 2022

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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