Sr. Executive - QMS P&E - INJ

Job Description:

Responsibilities

•  Ensure all engineering activities are executed in compliance with cGMP, GEP, and site SOPs.
•  Ensure compliance with Quality Management Systems (QMS) and applicable regulatory guidelines.
•  Handle all quality documents related to engineering such as Change Controls, Deviations, CAPA, and Quality Risk Management.
•  Review and update the respective planner and ensure compliance of activity on time.
•  Prepare and revise SOPs for plant machinery, utilities, HVAC, and water systems.
•  Support preventive maintenance execution as per the defined PM schedule and SOPs.
•  Assist engineers in installation and commissioning of new equipment.
•  Ensure effectiveness of training through review, feedback, and improvement initiatives.
•  Draft and update Job Descriptions for department personnel based on roles and responsibilities.
•  Act as the Training Coordinator for the Maintenance Department.
•  Update classroom/adhoc training records in training software.
•  Generate re-training requirements for SOP changes or compliance gaps.
•  Prepare, review, and revise training matrices as per SOP changes or department needs.
•  Identify and update training needs (TNI) and ensure compliance with training requirements.
•  Manage user creation/inactivation and credential sharing in AIMS software or equivalent systems.
•  Ensure new joiners are trained according to function mapping and training plan.
•  Upload training materials (new/revised SOP copies) and track completion.
•  Attend scheduled trainings and ensure personal and departmental training compliance.