Validation Analyst

Overview :

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is an American multinational information technology services and consulting company and is a leading provider of information technology, consulting, and business process outsourcing services, dedicated helping the world's leading companies build stronger businesses.

Title: Validation Analyst

Work Location : Rockville MD 99999

Duration: 12 months

Job Type: Contract

Work Type: Onsite & Remote

Application Skills

R&D and Pharmacovigilance GxP systems, ARGUS

Documentum or any document management system such as EDMS

MicroFocus ALM (Test Management Tool)

Mandatory Domain Knowledge

8+ years of Experience in Life Sciences, Computer System Validation

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

End client requires vaccination,

Years of Experience

8 Years of Experience

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.
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