Sr. Executive - QMS P&E - INJ
Job Description
Key Responsibilities:
Compliance & Documentation:
· 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.
Department Training Coordinator 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.
Layout Preparation and Drawing Management:
· Prepare and develop engineering layouts, floor plans, equipment layouts, and utility layouts for new and existing projects using AutoCAD and related software.
· Create detailed technical drawings based on specifications provided by the engineering and project teams.
· Collaborate with project engineers, production, and utility teams to gather requirements and translate them into accurate and efficient layouts.
· Maintain proper storage, version control, and backup of all drawings received from vendors and those prepared internally.
· Review and validate vendor-provided drawings for technical accuracy and compliance with project standards.
· Conduct site measurements to verify and update "as-built" layouts post-installation.
· Generate drawing revisions based on feedback and ensure internal approvals are obtained before final release.
Audit Readiness & Support:
· Ensure all systems, documents, and areas are audit-ready at all times.
· Participate in regulatory, customer, and internal audits, and coordinate timely closure of audit observations.
· Maintain compliance trackers and generate regular reports for the HOD and QA.
Other Duties:
· Perform additional assignments or responsibilities as assigned by the Head of Department (HOD).
· Contribute to continuous improvement initiatives within the department related to Operation and documentation.
Qualification: B.E (Mechanical / Electrical)
Experience: 4-6 years