Job Details
To have thorough understanding, practical approaches for Computer system validation (CSV)of enterprise level applicationsTo create CSV deliverables for IT projects eg, URS, FRS, CRA, IQ, OQ, PQ, RTM, VSR, Riskassessment, etcPerforms test script execution and completes validation documentation for simple tomoderate edit checksPerform Edit check/Listing Validation activities according to relevant clients SOP's andappropriate regulationsReview Data Validation or Listing Specification document created by study teamTest the clinical study database, as per procedureWork closely with other supporting departments to ensure all testing issues are resolved in atimely manner and study timelines are metTo guide and train IT & CSV teams for CSV, Data Integrity and Regulatory Complianceactivities.
To work along with CSV & Project Manager to ensure project timelines are metExperience on validation of any of the enterprise level applications