omer abdulla

• Conducted Gap Analysis to evaluate compliance with ISO standards • Created policies, procedures, and documentation for quality, health & safety, and environmental compliance. • Used tools like Minitab, Visio for process mapping, and Six Sigma methodologies to enhance operational performance. • Conducted internal audits and prepared businesses for third-party audits. • Provided training sessions and workshops on quality standards and best practices, which enhance employee performance by more than 40%.

• Developed an HVAC qualification master plan, supervised execution, & ensured all critical tests were conducted in compliance with ISO 14644 requirements & cGMPs. • Implemented comprehensive protocols for thermal qualification (SIP qualification & autoclave qualification) • Reduced sampling testing cost by developing and implementing a cleaning validation program. • Conducted a process validation program for critical products; identified critical-to-quality

participated in making contingency plan to move stored products and continue operations in safer locations • Ensured proper storage conditions (e.g., temperature, humidity, packaging integrity) are maintained during transit. • Conducted a gap analysis between the old and new operating locations. • Identified potential risks in transportation, storage, and production at the new site

• Developed and maintained quality management system standard operating procedures (SOP) that improved product quality and customer satisfaction by 30% in one season. • Led process mapping (Visio) and Six Sigma DMAIC projects, reducing spoilage by 80% and improving delivery efficiency. • Controlled process deviation and managed material and product nonconformity, insured implementation of effective corrective actions that reduced losses by more than 60%

• Built QMS ensuring alignment with ISO 9001 standards • Initiated a comprehensive process validation program that ensures that the process is under control and improved process capability to be more than 1 through control of critical process parameters • Designed and supervised a cleaning validation program that ensured 100% of all previous product traces are below the maximum allowable carryover • Developed and implemented an internal audit program that reduced gaps in the quality management system by 50%