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Validation and Qualification Lead
Job Responsibilities:Act as Validation and Qualification Lead on a large global laboratory remediation projects, with specific focus on Laboratory Standalone COTS systemsAuthor the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.Assist systems users with defining and documenting system use in user, admin, and maintenance SOPsCoordinate alignment of systems users from various company sites, including international sites, on validation and qualification documentationProactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectivelyProvide tactical guidance and coaching in support of systems testing effortsAct as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.Job Qualifications:7+ years of Lab Systems CSV experienced is required. 10+ years are desiredSpecific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are requiredUnderstanding of Data Integrity concepts is requiredExperience working with systems users from different sites is required. Experience with international sites is highly desired.Excellent communication and written skills required.