• Created the Validation Test Plan and Test Criteria• Followed Computer Systems Validation Master Plan to author, review and approve CSV deliverables for systems as per GxP , GMP, cGMP FDA Assessment• Authored, reviewed and approved CSV deliverables Project and Quality Execution Plan, Engineering Plan, Validation Project Plan, URS, TM,CMP,DRP,DCC,DRI,CIL,FRA, CRP,CRR,SFAT, UAT, Validation Protocols IQ/OQ documentation, Periodic Review Report, SOP and Validation Summary Report according… Show more • Created the Validation Test Plan and Test Criteria• Followed Computer Systems Validation Master Plan to author, review and approve CSV deliverables for systems as per GxP , GMP, cGMP FDA Assessment• Authored, reviewed and approved CSV deliverables Project and Quality Execution Plan, Engineering Plan, Validation Project Plan, URS, TM,CMP,DRP,DCC,DRI,CIL,FRA, CRP,CRR,SFAT, UAT, Validation Protocols IQ/OQ documentation, Periodic Review Report, SOP and Validation Summary Report according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries• Validated systems used for GMP and Non-GMP purpose• Excellent Knowledge and experience in Good Documentation Practices• Well versed in phases of Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC)• Strong understanding of V-module in compliance of GAMP5• Good understanding of data integrity on Audit trail, Logical securities and user privileges in compliance to 21 CFR Part 11• Test Lead on Manufacturing Execution System i.e. Syncade• Good understanding on various test methodologies -GUI Testing, Functional Testing, Regression Testing, Integration Testing, , Factory acceptance Testing and User Acceptance Testing• Involved in test activities of software Category 3, 4 and 5• Well versed on various MES modules i.e. Equipment, Inventory, ERP order and Equipment Workflows, Material Management, Document Control & Archiving and Reports• Create, Execute and Test on various Equipment Process recipes workflows like clean/Autoclaved, Part Washer, Sterile Plate check, Ambient Thaw Material etc• Interface testing of MES system in communication with Automation system, LIMS and ERP system• Good hands on Quality centre 9.0, 9.2, Mantis, Microsoft Test manager, TFS• Basic knowledge of QTP, VB Scripting and SQL Database Show less