Team Member -QA

Roles & Responsibilities

• Oversee the operation and maintenance of critical engineering systems—including mechanical equipment, HVAC, WFI, PW, and steam—to ensure continuous availability and optimal performance.
• Ensure compliance with GMP, FDA, and local regulations by conducting internal audits, managing documentation, and implementing corrective and preventive actions using tools like Why-Why analysis, Kaizens, and Poka-yoke.
• Lead engineering projects from initiation to completion, including resource planning, budget estimation, vendor coordination, and timely execution of instrumentation modifications.
• Develop and monitor preventive maintenance schedules in SAP, execute calibrations as per SOPs, and improve maintenance practices to reduce equipment breakdowns.
• Coordinate with cross-functional departments such as SHE, QA, QC, Production, IT, and Finance to ensure seamless maintenance and utility service delivery.
• Drive energy efficiency and cost optimization by implementing conservation techniques, monitoring utility generation costs, and maintaining records of energy consumption.
• Mentor and train engineering teams on maintenance procedures, safety protocols, hazard identification, and compliance with work permit requirements.
• Prepare and execute equipment qualification and validation schedules—including URS, DQ, IQ, OQ, PQ—and ensure documentation accuracy through cross-functional collaboration.
"

Function: Other
Experience Level: Mid-Senior Level