Csv Engineer

Computer System Validation Engineers-JD

Education: B.Tech/ Diplomo/ Bsc/ B.com in computers

Type of Activity: -

Service field computer system validation in pharma industrial

Must have good knowledge on IQ, OQ and PQ Protocols

Must have good knowledge on 21 CFR

To have thorough understanding, practical approaches for Computer system validation (CSV)
of enterprise level applications.
To create CSV deliverables for IT projects e.g., URS, FRS, CRA, IQ, OQ, PQ, RTM, VSR, Risk
assessment, etc.
Performs test script execution and completes validation documentation for simple to
moderate edit checks
Perform Edit check/Listing Validation activities according to relevant clients SOP's and
appropriate regulations
Review Data Validation or Listing Specification document created by study team
Test the clinical study database, as per procedure

Work closely with other supporting departments to ensure all testing issues are resolved in a timely manner and study timelines are met
To guide and train IT & CSV teams for CSV, Data Integrity and Regulatory Compliance
activities.
To work along with CSV & Project Manager to ensure project timelines are met.
Experience on validation of any of the enterprise level applications.

Skills

MS WORD

MS EXCEL