Senior Officer Mechanical Engineering Documentation

Amneal Pharmaceuticals; India; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Sr Officer – Engg QMS to lead and strengthen Engineering QMS processes, CAPA, deviation handling, and documentation. The role requires hands-on AutoCAD drafting for P&IDs and layouts, plus involvement in equipment qualification activities (DQ/IQ/OQ) and maintenance planning.

Ideal candidates will bring 4–8 years in regulated manufacturing with strong communication skills and experience in document control.

Qualifications

• 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.

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

P&ID drafting

DQ/IQ/OQ

MS Office

Equipment maintenance

Communication

Regulated manufacturing

Vendor coordination

Education

BE/B.Tech in Mechanical Engineering

Tools

AutoCAD

Job description

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

Qualifications

Experience: 4 to 8 Years
Qualification: BE/B. Tech in Mechanical Engineering.