Immediate Interview Validation Analyst Location: New Jers Job Opening in Jersey City, NJ

Job Title: Validation Analyst

Location:  New Jersey

Duration: (Contract)

 Description-

•R&D and Pharmacovigilance GxP systems, ARGUS

• Documentum or any document management system such as EDMS

- MicroFocus ALM (Test Management Tool)

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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