Quality Engineering Specialist

Responsibilities :

• Lead and manage reliability improvement projects within operations and engineering.
• uthor and review Change Control and Quality documents related to product or process modifications.
• Maintain operational compliance with US and international regulatory standards (FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).
• Review and support validation activities (equipment, cleaning, and process).
• Prepare for and participate in regulatory and internal audits.
• ct as the QA contact for risk management activities, including FMEAs.
• Investigate deviations, OOS results, and customer complaints, ensuring timely closure with appropriate corrective and preventive actions.
• nalyze and report batch data to identify trends and compliance risks.
• Develop, review, and revise SOPs, Batch Records, and training documentation with proper change control.
• Collaborate cross-functionally to drive problem-solving and continuous improvement across operations.

Requirements :