Hussein Ahmed

Key Responsibilities:

• Lead IPC team to ensure full compliance with GMP during manufacturing and packaging
• Oversee sampling activities (IPC, stability, reserve samples) ensuring accuracy and compliance
• Review and approve Points of Inspection (POI) before batch release
• Monitor production timelines to prevent out-of-hold-time risks
• Ensure implementation of cephalosporin contamination control strategy
• Approve release of semi-finished goods (SFG) post-production
• Support execution of process validation, cleaning validation, and hold time studies
• Review and approve change controls, deviations, and investigations
• Ensure timely closure of non-conformances and CAPAs with zero overdue
• Lead investigations for OOS results and market complaints
• Develop and approve Quality Risk Management (QRM) documents
• Coordinate training programs and ensure 100% TMS compliance
• Support successful external GMP inspections
• Provide QA support for new projects and site expansions

Key Achievements:

• Maintained zero overdue CAPAs and actions
• Participated in regulatory audits (SFDA, EDA, Abbott) with zero critical and major observations
• Contributed to successful GMP audits with no critical findings
• Ensured full compliance in IPC and batch documentation review
• Identified root cause of unsatisfactory IPC sampling issues on oral solid (OS) lines and implemented effective CAPAs, improving process reliability
• Led root cause investigation of analytical method gap for sterile powder vial products, where multi-component products were incorrectly tested as single component; implemented CAPA to correct methodology
• Identified and corrected assay test method gap for oral suspension products, shifting from volume-based to weight-based sample preparation to ensure accuracy and compliance
• Contributed to sterile production line upgrades through multiple investigations, including implementation of (New feeder system - Stainless steel machine wall filters - Point-of-use microbial filtration before washing machine - Enhanced sampling evaluation using AQL approach)

• Established full Quality Management System (QMS) including policies, procedures, and processes
• Developed SOPs and batch records for manufacturing control
• Implemented batch coding and document control systems
• Led customer complaint investigations and CAPA implementation
• Prepared organization for audits and improved compliance
• Developed process mapping across all operations
• Implemented finished product release system and retain sample control

Key Achievements

• Led IPC team ensuring adherence to GMP and internal procedures
• Managed deviations, investigations, and root cause analysis
• Participated in regulatory audits (SFDA, EDA, JFDA)
• Supervised process validation and SIP validation activities
• Reviewed BMR/BPR before product release
• Improved production efficiency through process optimization initiatives
• Trained new staff and enhanced team performance
• Proposed and implemented production line modifications to enhance productivity and reduce process waste
• Performed capacity analysis for Rommelag machines, optimizing operational efficiency
• Monitored and reduced waste levels for both bulk solution and primary packaging materials (PE granules) through data tracking and process control initiatives

• Supervised QA activities across multiple production lines
• Performed IPC sampling and in-process checks
• Reviewed batch records for compliance and completeness
• Monitored sterile manufacturing processes and environmental conditions
• Supported validation of sterilization processes and autoclaves
• Managed deviations, OOS, and change controls