Engineering - QMS - Sr. Executive

Engineering: QMS & DTC Coordinator –

• Engineering QMS Oversight: Drive and oversee all Quality Management System activities within the Engineering and Maintenance department, including Deviations, CAPAs, Change Controls, and OOS/OOT investigations.
• Documentation & Technical Control (DTC): Manage the Engineering DTC cell; maintain, update, and archive equipment history files, engineering drawings (P&IDs, HVAC, electrical), user requirement specifications (URS), and SOPs.
• Audit Representation: Serve as the primary Engineering SME coordinator during internal, customer, and regulatory audits (USFDA, EU GMP, WHO), presenting utility logs, maintenance records, and qualification files.
• Qualification & Validation Coordination: Coordinate equipment, facility, and utility re-qualification protocols (IQ/OQ/PQ) alongside validation, QA, and external service vendors.
• Preventive Maintenance (PM) Tracking: Track, schedule, and document factory-wide Preventive Maintenance schedules and calibration programs for processing machinery and critical utilities.
• Data Integrity Enforcement: Ensure all engineering logbooks, BMS/SCADA trend records, temperature/humidity graphs, and maintenance execution sheets adhere strictly to ALCOA+ data integrity principles.
• Vendor & Service Management: Review technical reports, service work orders, calibration certificates, and IQ/OQ/PQ execution dossiers submitted by third-party OEMs and contractors.
• Risk Assessment & RCA Lead: Lead failure mode and effects analysis (FMEA) and root cause analysis (RCA) for critical utility interruptions or equipment-related production failures.
• SOP & Protocol Authoring: Draft, revise, and route new Engineering SOPs, maintenance checklists, emergency breakdown procedures, and calibration guidelines through the electronic QMS.
• EHS & Training Compliance: Ensure engineering compliance with Environmental Health & Safety (EHS) guidelines, permit-to-work systems, safety interlock checks, and technical training tracking for maintenance staff.