Sr. Executive - QMS P&E - INJ

RXinsider LTD.; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

RXinsider LTD. is seeking an experienced Maintenance/Engineering professional to ensure cGMP-compliant engineering activities and robust documentation.

The role focuses on SOP development, QMS implementation, and training effectiveness across plant systems. The candidate will prepare detailed layouts using AutoCAD, maintain as-built records, and support audits with a proactive approach to continuous improvement.

Qualifications

• B.E. in Mechanical or Electrical engineering.
• 4-6 years of relevant experience in maintenance, engineering documentation and compliance.
• Experience with layout preparation, drawings, and project coordination.

Responsibilities

• Ensure engineering activities comply with cGMP, GEP, and site SOPs.
• Maintain QMS documents including Change Controls, Deviations, CAPA, and Risk Management.
• Prepare and revise SOPs for plant machinery, utilities, HVAC and water systems.
• Support PM scheduling and training effectiveness.
• Prepare engineering layouts and drawings using AutoCAD; verify as-built layouts.
• Audit readiness and coordination for regulatory and internal audits.

Education

B.E (Mechanical / Electrical)

Tools

AutoCAD

AIMS software

Job description

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.

Qualifications

Qualification: B.E (Mechanical / Electrical)

Experience: 4-6 years