Sr.Validation Engineer

Position: Sr.Validation Engineer

Exp : 6 to 8 Yrs

Location : Hyderabad

Shifts: Yes (UK & US)

Skills Required:

• 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.

Please mail your updated resume to careers.ind@eoktechnologies.com

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