Industry 4.0 - Bengaluru | Zoek India
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Industry 4.0-COTS MES-Lead
Permanent (Full time)
tMinimum 5-8 years and more experience of CSV n tMust have experience in CSV with end to end document creation and review like Validation master plan, GxP assessments, Part 11 requirements, user requirements, IQ, OQ, PQ testing protocols, test scripts, cases and reports, RTMs, Validation summary report, defect management, deviation and change control management nGood understanding of regulatory of needs wrt at least 2-3 of the standards/process GAMP, GxP, CSV, 21 CFR Part 11, ICH Q8/Q9 etc, FDA regulations like part 210, 211, 11, 820, 198 Product Quality and Compliance Business processes like Product Quality complaint management, Pharmacovigilance, Drug safety, Clinical trial process management "As a Lead, you are responsible for managing a small team of analysts, developers, testers or engineers and drive delivery of a small module within a project You may serve as entry level specialist with expertise in particular technology/industry domain/a process / application / product. You are responsible for functionalechnical track of a project."