A company is looking for a Computer System Validation Lead responsible for planning, writing, implementing, and reviewing computer system validation protocols.
Key ResponsibilitiesCoordinate all computerized system validation activities and lead associated assessmentsDevelop, review, and approve system validation documentation including master plans and user acceptance testsFacilitate communication between IT and system owners for the implementation and modification of computerized systemsRequired QualificationsBachelor's level degree requiredMinimum of 8-10 years related work experienceExperience in GxP, CRO, Laboratory, or R&D environmentsKnowledge of GAMP 5, FDA (GMP), GLP, and EU Annex 11 requirementsStrong business analysis skills across GxP supporting SaaS products
Computer System Validation Lead
A company is looking for a Computer System Validation Lead responsible for planning, writing, implementing, and reviewing computer system validation protocols. ...
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Master’s degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or related fields, with 6 years of direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations. The Senior IT Engineer 2, CSV is the Subject Matter Exp...
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