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Validation Lead/ Manager

3 months ago


Rockville, Maryland, United States Cognizant Technology Solutions Full time

Validation Lead/ Manager

Rockville, MD or Princeton, NJ

Job Description:

Application Skills:

• Medical Device and R&D GxP systems

• Documentum or any document management system such as EDMS

• MicroFocus ALM (Test Management Tool)

Mandatory Domain Knowledge:

10-12+ years of Experience in Life Sciences, Computer System Validation

Medical Device (Software As Medical Device) validation 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

Roles & Responsibilities:

• Manage GxP projects across Medical Device, Enterprise R&D systems

• Manage and supervise teams

Technical Skills:

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