Areas of Validation under my responsibility are,- Equipment Qualification (Sterile and Non-Sterile)- Utility Qualification- Facility Qualification- Computer System Validation- Thermal MappingDescription of responsibilities:• Review User Requirement Specifications (URS), perform Factory (FAT) and Site (SAT) Acceptance Testing, conduct Design (DQ), Installation (IQ), Operational (OQ), and Performance (PQ) Qualifications for GMP utility systems and manufacturing equipment, following FDA, WHO, ISPE, ICH, MHRA, and ASME guidelines.• Execute Computer System Validation for systems impacting business processes, complete risk and impact assessments based on GAMP 5 guidelines.• Write and execute qualification protocols including IQ/OQ and PQ, develop relevant procedures and set acceptance criteria.• Handle change control documents, manage deviations, conduct investigations, and oversee CAPA procedures.• Review preventive maintenance SOPs for equipment and systems, assist with corrective maintenance tasks.• Assist in creating and updating validation master plans, validation project plans, SOPs, risk assessments, user requirements, and technical assessment reports.• Coordinate and guide contract personnel involved in validation activities.• Support gap assessments, and implement corrective and preventive actions related to validation.

My Major Contributions to the Project Includes:-Redesigning of Factory Layout.-Making Project Timeline using Ms Project by mutual consent of all the vendors and contractors.-To keep the track of all the series and parallel Project activities. -Cost Estimation of the Project.-Assistance in the Design of Electrical Layout and Load Calculations of the Plant.-Cost Cutting of the Project.-Complete assistance to project manager and staff in installation of printing & die cutting machines and corrugation plant from rigging to commissioning.-Assistance in foundation and Placement drawings of the machines.-Design communication to vendor for a 15000 sqft Pre-Feb Shed.