Syed Abdhahir A
Qa Ecompliance Manager @Sandoz
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WORK HISTORY
Qa Ecompliance Manager @Sandoz
IN
EDUCATION
Annamalai University
Bachelor of Engineering in Computer Science and Engineering
ABOUT SYED ABDHAHIR A
16+ years of experience in the Computer System Validation (CSV)• Currently providing Quality and Compliance Support for SAP systems• Good exposure in SAP Solution Manager• Good knowledge in SOX controls, implementation and audit for IT Operations• Good knowledge in Information System’s Quality Management System (QMS) Processes such as SDLC and Change Control Procedures. • Provided Quality and Compliance Support for Application Development and Application Maintenance projects• Familiar with FDA, 21 CFR Part 11, GxP requirement along with knowledge of GAMP• Good Experience in Computer System Validation Testing (IQ, OQ & PQ)• Engaged with project teams to identify Quality, Compliance issues, provide CAPA and track it down for closure.• Involved in Supporting Audits (Internal & External)• Good experience in Computer System Validation methodologies• Good exposure in risk based validation approach for Computer Systems• Involved in Validation Plan and Validation Report preparation. • Provided end to End support in tracking and maintain all the validation deliverables in projects.
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