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Validation Lead/Manager

Company: Cognizant
Location: Rockville
Posted on: June 18, 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
Qualification and De-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: 10+ years of Experience in Life Sciences, Computer System Validation, Pharmacovigilance knowledge, hands on GAMP 5 Risk Based Validation, Functional Risk Assessment, GXP Assessment, 21 CFR Part 11 Assessment

Keywords: Cognizant, Rockville , Validation Lead/Manager, Executive , Rockville, Maryland

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