Perkin Elmer India - Mumbai, Maharashtra - Design, Author, and Execute Computerized System Validation (CSV) according to GAMP 5 guidance especially on Analytical Laboratory Test Equipment and other Lab Information Systems. Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents. Translate technical information and requirements into qualification/validation test design. Contribute to the overall growth of PerkinElmer s compliance business Qualifications, Skills and Experience: Bachelor s Degree; scientific background preferred At least 3-5 years of pharmaceutical of FDA related validation experience Good knowledge of GMPs, 21CFR Part 11, USP 1058 and other relevant industry regulations and guidance Strong interpersonal skills and demonstrated ability work independently Organi...
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