Skills
Configuration Management, Code Review, data integrity, GUI, Functional Testing, Regression, Integration Testing, Interface, ERP, Software Development Life Cycle, SDLC, STLC, bugs, bug fixes, Team Foundation Server, Jira, Quality Centre 9.0, 9.2, Mantis, Microsoft Test manager, Quick Test Professional, VB Scripting, SQL Database, Risk Assessment, TFS, SQL, V module, Software testing, Documentation, Microsoft word, Microsoft excel, Microsoft Visio, QTP, Quality center 9.0,9.2, SharePoint, Quality management system, Doc pro, Jira Scrum
Implemented GAMP 5 Risk Based Approach Validation Framework and QMS checklist.
• Process improvement-performing gap analysis and remediation activities
• Authored, reviewed and approved Computer System validation CSV deliverables like Project and Quality Executions Plan, Engineering Plan, Validation Project Plan, Traceability Matrix, Configuration Management Plan, Design Review Procedure, DCC, DRI, Configuration Item List, Functional Risk Assessment, Code Review Plan, Code Review Report , Software Factory Acceptance Test, User Acceptance Test, Validation Protocol Installation Qualification/ Operational Qualification documentation, Periodic Review Report, Standard Operating Procedures, Design Review Report and Validation Summary Report according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries.
• Validated systems used for Good Manufacturing Practices and to prove that the data lifecycle is complete and accurate.
• Excellent Knowledge and experience in Good Documentation Practices.
• Exceptional 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.
• Plan and ensure the data integrity parameters such as ALCOA+ for the entire data life cycle of the system
• Good understanding on various test methodologies -GUI Testing, Functional Testing, Regression Testing, Integration Testing, Web base Testing, Factory acceptance Testing and User Acceptance Testing.
• Involved in test activities of software Category 1, 3, 4 and 5.
• Hands on Manufacturing Execution System modules i.e. Equipment, Inventory, Enterprise Resource Planning 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
• Conduct training for project team to impart knowledge on quality.