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Keywords / Skills : Incident Management

2 - 5 years
Posted: 2019-07-21

Industry
ITES/BPO
Function
IT
Posted On
21st Jul 2019
Job Ref code
124817
Job Description
Job Description :

ExpertiseinvalidationofenterprisewideQualityITsystemsusingestablishedComputerSystemValidation(CSV)methodologysuchasGAMP5andFDAguidelines.StrongbackgroundonFDA,andEUregulationsforPharmaandhealthcare.
•ExperienceintoVariousimplementationmethodologieslikeVModel.
•ExposureintoComputerSystemValidationActivitiesasperFDAregulationsand
GxP(GLP,GCP,andGMP)guidelines.
•ProficiencyinQualityAssurance,RequirementAnalysis,FunctionalTesting,Validation&VerificationandTestPlancreationandexecution.
•ExperienceinsupportingvariousITAudits(USFDA,MHRA,ANVISA...Etc).
•ExperienceinImplementingProjectssuchasLMS,DMS,SCADA,ERP…EtcasperGMPGuidelines.
Key Skill(s)

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