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VL – EBS + Serialization
Ref No.: 18-15317
Location: Foster City, California
Experience Mandatory domain Mandatory validation skills Application / Technology / Role specific skills
9 – 12 years LS · 21 CFR Part 210 / 211
· GAMP 5 Risk Based validation / ICH Q9 hands on implementation knowledge
· Manufacturing, Distribution process and procedure
· Experience in managing large implementations / upgrade project
· Strong knowledge on change management procedure & process; Should have handled more than 20+ change requests
· Hands on knowledge on Deviation and CAPA Management
· Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
· Must 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