Sr. Executive - QMS P&E

As an Engineering Compliance Specialist, your primary role will be to ensure all engineering activities are carried out in compliance with cGMP, GEP, and site SOPs. This includes handling quality documents such as Change Controls, Deviations, CAPA, and Quality Risk Management. You will review and update the planner to ensure activities are completed on time and prepare/revise SOPs for plant machinery, utilities, HVAC, and water systems. Additionally, you will support preventive maintenance execution, assist in equipment installation/commissioning, and ensure effective training through review and feedback. Your responsibilities as a Department Training Coordinator will involve updating training records, generating re-training requirements, preparing/reviewing training matrices, and managing training needs. You will also ensure new joiners are trained according to the function mapping and training plan, upload training materials, and track completion to maintain departmental training compliance. In Layout Preparation and Drawing Management, you will develop engineering layouts, floor plans, and technical drawings using AutoCAD. This includes collaborating with project engineers and utility teams to create accurate layouts, maintaining drawing storage/version control, and validating vendor-provided drawings for accuracy. You will also conduct site measurements, generate drawing revisions, and ensure audit readiness at all times. Your role will also involve supporting audit activities, participating in audits, and ensuring timely closure of audit observations. Additionally, you may be required to perform other duties as assigned by the Head of Department and contribute to continuous improvement initiatives within the department related to operations and documentation. This company emphasizes a culture of compliance, quality management, and continuous improvement within the engineering department.,