Najiba Barakzai

• Performed Group Lead responsibilities, directed workflow and supported operators to ensure efficient, uninterrupted execution of high-priority production activities.
• Directed Pharm Surge production across sterile and non-sterile lines (17, 22, 13, 14, 12, Loading, Infinity, Kit Lines, Offline), optimizing daily operations, staffing, and resource utilization.
• Completed and maintained all CAPA documentation for production lines in alignment with GMP and SOP standards.
• Acted as SAP program's Super User, driving a 27% reduction in manufacturing data entry errors through process improvements and team training.

Projects: Alcon Manufacturing – Fort Worth, TX

• Kaizen Improvement Project – Line 17 (Sterile Fill & Packaging), Pharm Surge Department: Led a Kaizen improvement initiative for the Line 17 sterile fill and packaging process (Japan product ), identifying operational inefficiencies, performing root cause analysis, and implementing workflow enhancements that improved line performance, safety, and overall production efficiency. (08/2025-Present)
• Audit Compliance Support Project – Aspex Department: Delivered zero-finding audit results for the Aspex department by conducting comprehensive documentation reviews, resolving discrepancies, preparing audit-ready files, and ensuring full alignment with internal standards and cGMP requirements. (2024)
• Shutdown MBR Compliance Project – CLC & Pharm Surge Department: Coordinated the shutdown documentation initiative by updating, reviewing, and completing all Master Batch Records (MBRs) for both CLC and Pharm Surge operations. Ensured accuracy, GMP compliance, and operational readiness for restart through close collaboration with QA, Engineering, and Production teams. (2023)

• Managed operations across multiple store locations, driving sales performance, resolving staffing issues, and ensuring consistent execution of company standards.
• Drove performance improvements by reviewing store KPIs, identifying operational gaps, and implementing corrective actions that strengthened sales execution and customer satisfaction.
• Provided hands-on leadership to store managers through coaching, training, and performance development, improving team capability and operational discipline across all assigned locations.