Senior Officer, Mechanical Engineering Documentation

Amneal Pharmaceuticals; Dahej; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Dahej, India, seeks a Sr Officer – Engg QMS to lead Engineering QMS processes, CAPA and Change Control, and support equipment qualification and validation activities.

You will prepare 2D drawings, P&IDs, and documentation, coordinate with vendors, and ensure QMS compliance in a regulated pharma environment. 4–8 years of relevant experience required.

Qualifications

• Experience in Engineering QMS and document control.
• Strong knowledge of CAPA, Change Control, Deviations, and Root Cause Analysis tools.
• Proficiency in AutoCAD drafting, including P&IDs and layouts.
• Understanding of equipment qualification (DQ/IQ/OQ).
• Knowledge of mechanical equipment installation, commissioning, and maintenance.
• Effective communication and coordination abilities.
• Good command of MS Office (Word, Excel, PowerPoint).
• Experience in pharmaceutical, chemical, or regulated manufacturing environments will be an advantage.

Responsibilities

• Manage and improve Engineering QMS processes, including CAPA, Change Control, Deviations, and Root Cause Analysis.
• Monitor QMS compliance and provide regular status reports to management.
• Prepare and revise 2D engineering drawings, layouts, and P&IDs using AutoCAD.
• Control drawing numbering systems, revisions, and document registers.
• Review engineering drawings against specifications and coordinate approvals with vendors.
• Prepare and support execution of DQ, IQ, and OQ documentation.
• Support planning, installation, commissioning, and qualification of mechanical equipment.
• Assist in preventive and breakdown maintenance of process and utility equipment.

Skills

Engineering QMS

CAPA & Change Control

AutoCAD drafting

DQ/IQ/OQ

Mechanical maintenance

MS Office

Regulated manufacturing

Education

BE/B.Tech Mechanical Engineering

Tools

AutoCAD

P&IDs

Job description

• Manage and improve Engineering QMS processes, including CAPA, Change Control, Deviations, and Root Cause Analysis.
• Monitor QMS compliance and provide regular status reports to management.
• Prepare and revise 2D engineering drawings, layouts, and P&IDs using AutoCAD.
• Control drawing numbering systems, revisions, and document registers.
• Review engineering drawings against specifications and coordinate approvals with vendors.
• Prepare and support execution of DQ, IQ, and OQ documentation.
• Support planning, installation, commissioning, and qualification of mechanical equipment.
• Assist in preventive and breakdown maintenance of process and utility equipment.

Job Description

Title: Sr Officer – Engg QMS

Key Responsibilities

• Manage and improve Engineering QMS processes, including CAPA, Change Control, Deviations, and Root Cause Analysis.
• Monitor QMS compliance and provide regular status reports to management.
• Prepare and revise 2D engineering drawings, layouts, and P&IDs using AutoCAD.
• Control drawing numbering systems, revisions, and document registers.
• Review engineering drawings against specifications and coordinate approvals with vendors.
• Prepare and support execution of DQ, IQ, and OQ documentation.
• Support planning, installation, commissioning, and qualification of mechanical equipment.
• Assist in preventive and breakdown maintenance of process and utility equipment.

Required Skills

• Experience in Engineering QMS systems and document control.
• Strong knowledge of CAPA, Change Control, Deviations, and Root Cause Analysis tools.
• Proficiency in AutoCAD drafting, including P&IDs and layouts.
• Understanding of equipment qualification (DQ/IQ/OQ).
• Knowledge of mechanical equipment installation, commissioning, and maintenance.
• Effective communication and coordination abilities.
• Good command of MS Office (Word, Excel, PowerPoint).
• Experience in pharmaceutical, chemical, or regulated manufacturing environments will be an advantage.

Qualifications

Experience: 4 to 8 Years

Qualification: BE/B. Tech in Mechanical Engineering.