QMS Engineering Executive

Overview

Executive – Engineering (QMS) to manage engineering quality documentation and support QMS activities in a warehouse GMP context.

What you’ll do

• Implement quality assurance standards, processes, controls, and cGMP in warehouse operations.
• Prepare SOPs and ensure effective implementation.
• Manage deviations using deviation management SOPs.
• Handle change control and CAPA management for the engineering department.
• Support documentation for DQ, IQ, OQ, and PQ and ensure training for SOPs, GDP, cGMP, and on-the-job training.
• Manage routine requalification and validation for HVAC systems, compressed gases, and equipment.

What you’ll need

• 6–7 years of experience handling engineering department GMP documentation activities.
• BE in Mechanical/Electrical/Instrumentation or B Pharma (preferably BE).
• Working knowledge of deviation management SOPs.
• Familiarity with change control and CAPA management related to engineering.
• Familiarity with DQ, IQ, OQ, and PQ documentation.
• Experience working with QMS software like TrackWise.

Details

• On-site location: Mumbai, MH.
• Scheduled weekly hours: 48.