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Test Lead with LIMS
Ref No.: 17-07428
Location: Sunnyvale, California

Job Description:
1. Experience/practical understanding of Labware LIMS, STAR LIMS
2. Good functional knowledge on Oracle Inventory, and Manufacturing modules especially of Oracle Process Manufacturing
ü Computer System Validation
ü 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
· Disaster Recovery Qualification
· Qualification and Commission
· Validation coverage in IQ, OQ and PQ
· Deviation management process
· Validation Summary Reports
ü Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
ü Must possess formal training/certification on Testing & Validation
ü Excellent communication skills
ü Should have worked in cross-functional environments and comfortable to liaison with business