Overview

Validation Consultant to assess system compliance, or operational risks and develop risk management strategies. Evaluate the testing procedures, test parameters, validation procedures used by the computerized systems, equipment in Analytical labs, Clinical Labs and Manufacturing facilities. Conduct internal reviews and audits to ensure that compliance procedures are followed as per FDA 21 CFR Part 11, 21 CFR Part 820 regulations. Master¬Ěs Degree in Pharmacy/Information Technology related and 1 year of exp in FDA Quality System Regulation, 21 CFR Part (11, 210, 211, 820, 803, 806),  GAMP, IQ, OQ, PQ, RTM, SOPs, LIMS, ELN, AERS, Post Marketing Data Analysis, NCR CAPA required. Send Resumes to GSSR Inc, 14900 Bogle Drive, Suite 100, Chantilly, VA 20151

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