Samia Hadj-Hamou Email & Phone Number

Carrollton, Texas, United States

• Manage quality system activities both internally and externally, ensuring compliance with regulatory standards and customer requirements.• Lead quality system activities and provide recommendations for system improvements, method enhancements, and equipment optimization.• Design and implement quality assurance activities for design control, providing investigational support for non-conformance reports (NCRs), corrective and preventive actions (CARs/CAPAs), and customer complaints.• Assist in developing a stable, innovative, and compliance-focused quality assurance team, fostering cross-functional collaboration to troubleshoot manufacturing issues and achieve site objectives.• Participate in quality activities, interfacing with customers, suppliers, and internal stakeholders to implement corrective and preventive actions as necessary, utilizing risk assessment methodologies for written reports.• Ensure adherence to Good Manufacturing Practices (GMP) and quality system compliance by verifying the compliance of standard operating procedures.• Lead problem-solving and process improvement initiatives in collaboration with manufacturing, project managers, and customers to mitigate issues and enhance operational efficiency.• Analyze and prioritize demands, task assignments, investigation activities, risk factors, and data analysis to meet site objectives, customer requirements, and quality/compliance initiatives.• Initiate, write, review, and manage non-conformance reports (NCRs), corrective and preventive actions (CAPA), reworkplans, risk assessments, and other Quality Management System (QMS) documentation.• Author and approve product and process changes, new documents, through the site Change Management process.• Utilize root cause analysis, data analysis, and problem-solving techniques, including 6M, Fishbone, Is/Is Not, 5WHYs, statistical analysis, process control charts, and risk assessment methodologies.

Lewisville, Texas, United States

• First point of contact for specific third-party manufacturers, ensuring a full understanding of customer needs• Compliance checking and reporting, managing product nonconformance by facilitating investigations with third party manufacturers and packaging suppliers• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues • Perform AQL inspections of finished product stock to identify depth of any product issues including documentation of results and coordination with packaging department for any reinspection required• Shelf-life extensions, maintaining documentation of samples pulled/sent and test results, and documentation for extension requests• Laboratory chemical and physical testing on finished goods, analyzing, monitoring, documenting and communicating results of chemical and physical test of raw materials and liquid finished products• Notification of new products for importation into Canada • Creation of NAFTA and USMCA, supporting regulatory on product registrations for various countries• Knowledge of usage of Oracle • Oversees data collection and analysis for KPI monitoring • Supplier Validation, ensuring suppliers comply with domestic and international requirements• Manage the sample retain program focused on collecting and verifying production samples

Lewisville, Texas, United States

• Worked as the Regulatory Affairs Business Partner to cluster divisional teams: R&D (Cluster/Local/Global), Supply Chain (Quality, Procurement, Innovation planners, Logistics, and International Compliance & Trade), Regulatory Affairs Cluster Innovation/Advocacy (I/A), Artwork Excellence Team, and External Affairs/Legal• Supported Regulatory with product registrations, PIF creations and document control • Supported Quality by helping 3rd party manufacturers to understand TIGI expectations

Irving, Texas, United States

• Wrote qualification and validation protocols for a provider of kidney dialysis services and renal care products• Updating all related SOP to the new product • Participated in New Product Development and design changes, work with the Design History File (DHF) and Device Master Record (DMR) and ensure that design projects comply with internal design control procedures in accordance with FDA and ISO requirements

• Established, created, and monitored stability program for cosmetics, OTC products, and beverages• Wrote and oversaw the execution of Process Validation and Process Scale-up• Wrote and conducted Annual review for OTC product following FDA guidelines• Responsible for reviewing and approving, IQ, OQ, SOP and deviations• Authored cleaning validation SOPs and protocols that were favorably recognized in FDA inspection• Determined through statistical data continuous improvements projects, analyze data and/or trend analysis• Monitored, controlled, and analyzed product and process quality to meet customer requirements• Managed supplier qualification activities and raw material qualification for assigned commodities• Ensured site audit readiness, host the Quality System audits, and executes Quality Management System reviews.• Established quality metrics for the operations that drive awareness, action, and continuous improvement in quality• Communicated quality goals and requirements by preparing and disseminating standards, metrics, and standard operating procedures (SOP) management, and vendor document and production record guidelines• Trained and managed the workflow activities of subordinate Chemists

• Developed analytical methods like assay, related substance, and dissolution using HPLC under regulatory requirements with cGMP• Carries out dissolution profiling for abbreviated new drug application• Reviewed and prepared summary and validation reports of Analytical Method Validation on a per company basis; reviewed regulatory requirements• Utilized Waters Empower 1 Chromatography Data Software for HPLC sample analysis• Afforded operation and troubleshooting of sophisticated instrument in Lab, and executed small research and development scale up• Trained and managed the workflow activities of subordinate Chemists

• Executed content uniformity testing/kinetic drug release testing and resulting analysis of pharmaceuticals and drug coatings on medical devices• Perform full testing for identification, assay, stability, physical / chemical property, impurities, HPLC method validation and method transfer• Utilized Waters 2996 with Millenium32 and Empower 2 Chromatography Data Software for HPLC sample analysis• Recorded and summarized experimental data according to industry-accepted guidelines and protocols, including reporting on LIMS• Revised Sops as necessary, working effectively under cGMP conditions• Trained subordinate Chemists, ensuring processes workflow and procedures are properly understood, carried out and evaluated and that trends and/or modifications are investigated according to policies in place