Engineering QMS|| Pharma

Key Responsibilities:

Quality Management & Compliance

• Maintain and implement QMS processes for the engineering department.
• Track and resolve internal and external audit non-conformances and improvement observations.
• Handle deviation incidents, investigate engineering issues, and ensure effectiveness of corrective and preventive actions (CAPA).
• Perform quality risk and impact assessments for major facility changes.
• Initiate and implement change control, planned and unplanned deviations through electronic QMS software.
• Provide internal training on QMS compliance and process improvements.

Documentation & Regulatory Compliance

• Maintain engineering department documents in compliance with regulatory standards.
• Ensure data integrity and proper record-keeping.

Maintenance & Calibration

• Prepare and execute calibration and maintenance schedules for instruments using SAP.
• Operate, troubleshoot, and maintain electronic instruments such as sensors, controllers, transmitters, weighing scales, gauges, and PLCs in machines like granulation, coating, compression, packing, BMS/EMS, water systems, and utilities.
• Follow up and execute routine preventive, corrective, and breakdown maintenance activities.

Vendor & Spare Management

• Manage vendors for materials and services as required.
• Oversee critical spare management for breakdown and planned maintenance activities.
• Support site operations by reviewing calibration activities and addressing potential product impacts from out-of-calibration situations.