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Validation Engineer III - (Rocky Mount, NC)

Job Description: JOB OVERVIEW • Performed validation of Quality Control laboratories instruments (with and without computer systems) according to the site's applicable validation SOPs. • Authors validation deliverables as required. • Ensure that the system is installed and configured in a 21 CFR Part 11/Annex 11 compliant manner. • Provide validation ability and support to the Quality Control laboratories JOB RESPONSIBILITIES • Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories. • Authors cGMP risk assessments, user qualifications and function specifications, validation plans, protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs. Previous background with validation of laboratory instrument systems preferred.


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Posted in Rocky Mount, NC, Architecture & Engineering
From Net-Temps - 1 month ago