Officer To Executive QMS Engineering at Raks Pharma , Dahej ( Amneal )

Raks Pharma Pvt Ltd Dahej (A div. of Amneal Pharmaceuticals); Dahej; Sur place; INR 600 000 - 900 000; Plein temps

Résumé du poste

Raks Pharma Pvt Ltd Dahej (A div. of Amneal Pharmaceuticals) is seeking a Mechanical Engineer with strong QMS experience to manage CAPA, Change Control and deviations while preparing 2D drawings and P&IDs using AutoCAD.

The role requires coordination with vendors and supporting DQ/IQ/OQ activities in a regulated manufacturing environment. The candidate will monitor QMS compliance, maintain document control, and assist in maintenance planning and equipment qualification.

Qualifications

• Experience with Engineering QMS systems and document control.
• Strong knowledge of CAPA, Change Control, Deviations, and Root Cause Analysis.
• Proficiency in AutoCAD drafting, including P&IDs and layouts.
• Understanding of equipment qualification (DQ/IQ/OQ).
• Experience in pharma/chemical/regulatory manufacturing environments is advantageous.

Responsabilités

• Manage and improve Engineering QMS processes including CAPA, Change Control, Deviations, and RCA.
• Monitor QMS compliance and provide regular status reports to management.
• Prepare and revise 2D drawings, layouts, and P&IDs using AutoCAD.
• Control drawing numbering, 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.
• Effective communication and coordination abilities across teams.
• Good command of MS Office (Word, Excel, PowerPoint).
• Experience in pharmaceutical, chemical, or regulated manufacturing environments will be an advantage.

Connaissances

CAPA

Change Control

Deviations

Root Cause Analysis

AutoCAD

P&IDs

Drafting

Documentation

MS Office

Communication

Vendor coordination

QMS

Formation

BE/B.Tech Mechanical Engineering

Outils

AutoCAD

Description du poste

Role & 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.
• 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.

Preferred candidate profile

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