Sr. Executive - QMS P&E - INJ at Amneal… · Ahmedabad…

Qualification: B.E (Mechanical / Electrical) Experience: 4-6 years

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.

Qualifications

Qualification: B.E (Mechanical / Electrical) Experience: 4-6 years