Validation Test lead

• 9 - 12 years of Experience in Life Sciences, Computer System Validation (CSV)
  


• 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

• Must have experience of working in an onsite-offshore model

Technical Skills

* Proficiency Legends