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Validation Lead/ Manager
3 months ago
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