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Computer System Validation Specialist

2.00 to 3.00 Years   Mumbai City   03 Feb, 2021
Harjai Computers Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

We are looking for Computer System Validation Specialist with experience in CSV life cycle documents /qualification related protocols (like URS, FRS, FRA, DS/CS, IQ, OQ, PQ, RTM) for Mumbai LocationRequired Candidate profile

  • Understand clients CSV, Quality and Risk management strategy, define and align with the processes and procedures for the program/project
  • Assist in providing strategic inputs for CSV projects
  • Should have knowledge of GxP system, GAMP, 21 CFR Part11 software validation
  • Should be able to gather requirements (user/functional) clearly from multiple stakeholders
  • Able to prepare CSV life cycle documents /qualification related protocols (like URS, FRS, FRA, DS/CS, IQ, OQ, PQ, RTM)
  • Support in preparing test scripts annexures
  • Able to execute/ support in executing test scripts and recording results
  • Should understand serialization concepts in the pharmaceutical industry (SAP Advanced Track & Trace for Pharmaceuticals)
  • Able to handle the projects independently
,

Keyskills :
frsurscomputer system validationfatpackagingtest scriptsgxpcfrgamppharmaceutical industryrisktracerisk managementfocusfunctional21 cfrfralife cycle

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