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Validation Manager / Validation Lead
Ref No.: 16-09742
Location: Foster City, California
Need candidates with any one of the application skills which we mentioned below.
Application Skills
  • Oracle Agile PLM
  • Serialization
  • Regulatory Applications
  • Oracle EBS
  • Veeva or Salesforce or other SaaS Applications
  • Argus
Mandatory Domain Knowledge
  • 9 - 12 years of Experience in Life Sciences, Computer System Validation
  • 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
    • CAPA
    • Validation Summary Reports
  • Knowledge on Infrastructure IQ & qualification
  • 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