Urgent requirement || Validation Test Lead with Serialization @ Foster City, CA

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Vasanth Kumar

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Apr 3, 2017, 4:52:17 PM4/3/17
to vas...@aitrg.com

Hi, 

Greetings from American IT Resource Group Inc.! 

I would like to touch-base you regarding a job opportunity with our client, appreciate if you could go through below job detail and let me know your thoughts as soon as possible.

Reply only to vas...@aitrg.com

Role: Validation Test Lead with Serialization

Location: Foster City, CA

Duration: 6+ months contract 

Skills set:  Validation Testing, 21 CFR Part 11, Serialization 

Job Description:

  • Experience/practical understanding of OPSM (Oracle Pedigree Serialization Manager) testing
  • Good functional knowledge on Oracle Inventory, and Manufacturing modules especially of Oracle Process Manufacturing
  • 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
  • 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
  • Should have worked in cross-functional environments and comfortable to liaison with business

 

Looking forward to hear from you!

 

Thanks & Regards,

 

Vasanth || American IT Resource Group, Inc.

1111, Plaza Dr., Suite 640, Schaumburg, IL - 60173

Desk: 312-561-4349 || Email: vas...@aitrg.com

Skype/ Gtalk: vasanth.aitrg || Web: www.aitrg.com

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