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Validation Engineer + Serialization
Ref No.: 18-05251
Location: Foster City, CA, California
  • Experience with any of the listed tools is a must (Axway / MSCA / GEM / Oracle EBS)
  • 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