Engineering QMS Executive

About the role

The Engineering QMS Executive will oversee the quality management system for engineering activities within a regulated manufacturing environment. You will ensure that all engineering documentation, validation, and maintenance processes meet cGMP, GDP, and EHS standards.

Key responsibilities

• Manage engineering documentation, SOPs, training records, change controls, CAPA, and deviations.
• Execute routine validation for HVAC systems, utilities, and manufacturing equipment.
• Prepare, review, and maintain IQ, OQ, and PQ qualification documents.
• Plan, schedule, and monitor preventive maintenance for plant and utility equipment.
• Support online initiation, review, and closure of change controls, deviations, and CAPAs for Fill‑Finish operations.
• Monitor equipment performance, reliability, and generate trend reports.
• Prepare monthly engineering, utility consumption, and performance analysis reports.
• Conduct training programs and maintain training compliance records.
• Coordinate with Quality, Production, Maintenance, Validation, and other cross‑functional teams to resolve QMS issues.
• Participate in internal, customer, and regulatory audits and ensure audit readiness.

Required profile

• B.E/B.Tech/M.Tech/Diploma in Mechanical, Electrical, Instrumentation, Industrial Engineering or related discipline.
• 1–5 years of experience in engineering quality management within pharmaceutical or biopharma manufacturing.
• Familiarity with cGMP, GDP, EHS, and regulatory requirements (USFDA, MHRA, WHO‑GMP).

Required skills

• Change Control Management
• CAPA & Deviation Management
• QMS Documentation
• HVAC Validation
• Equipment Qualification (IQ/OQ/PQ)
• Preventive Maintenance Planning
• Equipment Performance Monitoring
• Root Cause Analysis (RCA)
• Data Analysis and Reporting
• MS Office / Documentation Tools