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Position Title

Computer System Validation Specialist

Function

Production

Supervisor

Scott Jordan

Division

Trial Interactive

Supervising

NA

Job Category

TransPerfect

OVERVIEW

N/A

DESCRIPTIONREQUIRED SKILLSResponsible for the continued compliance and further expansion of the TransPerfectcorporate Quality Management Systems (QMS) in the area of Computerised SystemsValidation within the Trial Interactive division and consulting to other TransPerfectdivisions as needed. This includes, but is not limited to, the following areas:Software Development Life CycleCOTS Validation and subsequent 3rd Party Vendor QualificationInfrastructure QualificationRegulatory Compliance EvaluationsValidation Package Reviews/ApprovalsOperational ReadinessPeriodic ReviewsChange ControlClient-specific Validation ServicesInvestigate validation specific complaints or adverse experiences and operationalproblems to identify root cause and effective corrective and preventive actions;provide the formal Client Escalation Report back to the clientActively maintain and improve colleagues’ awareness of Systems Validation processes,policies, and procedures through training and any other methodsTravel up to 20% domestically and internationally as required