6-8 Yrs experience of overall in IT Validation Engineering
Good experience in Computer System Validation (CSV), Equipment validation, Testing and technical documentation in adherence to FDA regulations
Need 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 Systems
Thorough 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.
Job Classification
Industry: IT Services & Consulting Functional Area / Department: Engineering - Software & QA Role Category: Software Development Role: Back End Developer Employement Type: Full time