Siraj Mohmmed

Sr Validation and Compliance Engineer @PerkinElmer

PA, US

Authored change control to initiate the upgrade of the ERP Implementation following the IT Change Management SOP• Execute change control for routine system updates• Patches, upgrades for laboratory systems in general• Design, develop, and implement automation solutions using DeltaV systems to optimize manufacturing processes and ensure regulatory compliance.• Implemented automated testing processes, reducing testing time by 50% and increasing team productivity by 25%.• Performed GxP applicability assessment and determined the GxP process Vs Non-GxP Process.• Performed Gxp System Risk Assessment in determining the risk imposed by the system • Worked with the Business owner of different departments in defining their business needs • Scheduling the demo sessions with the vendor involving various business users from multiple departments• Involved in gathering and documenting User Requirements and developing a Validation Plan• Worked as a liaison between business stakeholders and the vendor.• Authored and executed IQ, OQ, and PQ for Validation of all types of manufacturing equipment like filtration, systems, centrifuge, Chromatography, shakers, freezers, dryers, and refrigerators.• Worked with the vendor in performing the activities for the client as per the SOW • Assessed the vendor-provided validation documentation to leverage based on the Audit conducted• Prepared documentation of computer system validation lifecycle in accordance with FDA regulations including Validation Plan, URS, System Design and Configuration Document, PQ Test Plan, and Performance Qualification (PQ)