- 6-8 Yrs experience of overall in IT Validation Engineering . Positive experience in Computer System Validation (CSV),Equipment validation,Testing and technical documentation in adherence to FDA regulations .
- Extensive experience in writing Validation documents,Test Scripts and using various modules of the Track Wise QMS system
- 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.