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Engineering QMS Sr. Executive
Job Location:
Yearly Salary:
Posted:
4 September 2026 (4 days ago)
Posted:
Application Deadline:
2 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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.
Required Experience:
Senior Exec
