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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | IT - Software |
| Functional Area | TestingGeneral / Other Software |
| EmploymentType | Full-time |
Good experience in Computer System Validation (CSV), Equipment validation, Testing and technical documentation in adherence to FDA regulationsNeed to have through knowledge on Quality Systems and Standards (cGxP- cGLPs, cGCPs and cGMPs), GAMP 5 and regulation of drugs.Expertise in reviewing, modifying and writing Validation Deliverables such as Change Controls, Test Cases, Test Plan, Validation Plan(VP), Standard Operating Procedures(SOPs), Installation Qualification(IQs), Operational Qualification(OQs),Performance Qualification(PQs), Test Summary Report (TSR) , Validation Summary Report(VSR) and Traceability Matrix(TM) for Lab Systems as well as Quality SystemsThorough understanding and working understanding of Track Wise Quality Management System and its various modules.Extensive experience in writing Validation documents, Test Scripts and using various modules of the Track Wise QMS system.Strong Background in writing test scripts and conducting testing like Regression, Positive testing, Negative testing, System Testing and Performance testing.,
Keyskills :
validation debugging intel testcases customerrelations computersystemvalidation qualitymanagementsystem testscripts systemtesting qualitysystems managementsystem qualitymanagement tatementsofw ksow