Rafat Alghubari

Roles and Responsibilities: • Injectables & Sterile Expertise: Spearhead the Injectables Facility and Media Fill Projects as Project Manager, specializing in isolator cycle validation and lyophilizer qualification. • Innovative GMP Solutions: Developed systems for GMP compliance scoring during audits and employee training point tracking. • Quality Risk Management (QRM): Integrated QRM into document reviews, audits, deviation handling, and complaints management. • Leadership in Quality Assurance: Oversee QA across manufacturing, QC, R&D, engineering, and supply chain, fostering a culture of quality excellence. • Audit & Inspection Leadership: Lead internal, external, and regulatory audits, achieving compliance with global standards of multinational CMOs (Sanofi, Novartis, Aspen, Abbott, Janssen). • Document & Compliance Oversight: Approve key quality documents, QA agreements, and oversee market complaints, recalls, CAPA, and Annual Product Reviews. • Training Innovator: Conduct GMP training, create impactful training videos, and implement Human Error Reduction strategies. • Vendor & CMO Excellence: Conducted Vendor Validation & Certification Programs; lead CMO audits and compliance reviews.

Roles and Responsibilities: • Comprehensive Training Programs: Designed and implemented the annual GMP training program, developing engaging materials, videos, and presentations tailored to industry standards. • Innovative Training Frameworks: Established procedures for creating GMP training materials, defining objectives, and measuring training success and effectiveness. • Induction & Skill Development: Conducted induction training for new hires and managed On-the-Job Training (OJT) activities. • Performance-Linked Education System: Developed a GMP Maintenance Education Points System, linking annual GMP points to employee KPIs for enhanced accountability. • Outsourced Training Excellence: Managed and qualified outsourced trainers and training academies, ensuring alignment with GMP standards. • Audit-Ready Training Compliance: Implemented systems for calculating GMP compliance levels for training during internal and external audits.

Roles and Responsibilities: • End-to-End Quality Leadership: Directed QA activities across manufacturing, QC, R&D, engineering, and supply chain, building a strong quality-driven culture. • Team Development & Leadership: Managed and mentored the Quality Team, fostering crossfunctional collaboration and excellence. • Regulatory & Customer Audit Expertise: Acted as the lead contact for regulatory inspections and customer audits, ensuring compliance with global standards. • Documentation Excellence: Approved critical QA documents, including SOPs, QAAs, validation master plans, and market complaint investigations. • Process Innovation: Created systems for spot audits, product accountability, and AQL-based finished goods inspection. • CAPA & Risk Management: Oversaw deviation investigations, CAPA management, and recalls, ensuring timely resolution and compliance. • Advanced Validation Oversight: Approved and monitored site-wide validation plans for processes, cleaning, calibration, and computerized systems. • Audit Team Leadership: Led internal and external audit teams, driving compliance with global GMP standards. • Systems Implementation: Championed the deployment of the Novatek Computerized Quality Management System (QMS) to enhance site operations. • Warehouse & Equipment Mapping: Approving mapping studies for warehouses, incubators, stability chambers, and refrigeration units to ensure optimal conditions.

Roles and Responsibilities: • Quality Systems Improvement: Led initiatives to enhance and streamline quality systems across the company to ensure compliance with GMP standards. • Sterile Product Launch: Directed the successful media fill project, enabling the company to begin sterile product production. • Documentation Oversight: Reviewed and approved all departmental documents, ensuring regulatory alignment and adherence to quality standards. • AQL System Implementation: Designed and implemented the Acceptance Quality Limit (AQL) system for production and finished goods inspection, improving product quality. • Complaint & Deviation Management: Managed the implementation of market complaints and deviation control systems, driving timely resolutions and process improvements. • Change Control System Implementation: Developed and oversaw the implementation of a robust change control system. • Cleaning Validation System: Led the implementation of a comprehensive cleaning validation system across manufacturing operations. • Stability & Validation Protocols: Reviewed and approved stability procedures, protocols, and the Validation Master Plan, ensuring proper validation practices. • Process & Equipment Validation: Validated critical equipment, including tunnels and sterile area HVAC systems, and prepared media selection, lactose selection, and closure integrity testing protocols for aseptic filling. • Process Validation Oversight: Ensured the implementation of effective process validation systems, improving manufacturing consistency and product quality. • ISO 17025 Representation: Acted as the management representative for ISO 17025, ensuring the company’s compliance with global standards. • Internal Audit Leadership: Led internal audits, contributing to continuous improvements in the quality assurance framework.

Roles and Responsibilities: • Establishing Validation Department from scratch • Validation Department Establishment: Successfully built and established the Validation Department from the ground up, laying the foundation for future success. • Validation Master Plan: Developed and approved the comprehensive Validation Master Plan, ensuring alignment with industry standards. • Cleaning Validation: Created and approved the Cleaning Validation Master Plan, critical for maintaining product quality and compliance. • SOPs & Protocols Creation: Designed and approved Standard Operating Procedures (SOPs), protocols, and validation plans, ensuring robust and compliant validation practices. • Implementation of Validation Activities: Led the implementation of validation and qualification activities across critical areas of production. • Change Control System: Developed and rolled out an effective change control system to ensure quality and compliance in production processes. • Annual Product Review Procedure: Created the Annual Product Review Procedure to track and evaluate product performance and compliance. • Process Validation Protocols: Prepared and approved detailed process validation procedures and protocols, ensuring consistency and compliance with GMP standards. • Team Leadership: Managed and developed the Validation Department team, fostering collaboration and efficient resource utilization. • GMP Training Implementation: Delivered GMP training sessions to ensure compliance and maintain a high-quality standard across the company.

Roles and Responsibilities Summary: Leadership & Quality Culture: Managed QA resources, promoting a culture of GMP compliance and continuous improvement. Internal & External Audits: Led audits across departments, coordinated CAPA actions, and managed external audit observations. Daily Compliance Oversight: Conducted plant-wide GMP inspections to ensure regulatory adherence. Document Control: Reviewed and approved SOPs, validation protocols, and essential quality documents. Training & Development: Delivered GMP training sessions to ensure organizational compliance consistency. Critical System Monitoring: Oversaw qualification and operation of HVAC, compressed air, and water treatment systems. Incident Management: Followed up on incident investigations, ensuring corrective actions were effective and timely. Spot Audits: Conducted monthly audits in production, packaging, and warehouse areas to maintain continuous compliance. Media Fill Validation: Led media fill projects for aseptic filling, ensuring sterile product quality. Collaboration & Validation: Partnered with the validation team on cleaning protocols and readiness for operations. Change Control & Process Validation: Managed change control processes and led validation efforts to maintain consistency and GMP standards. Audit Leadership: Served as a lead auditor, driving improvements and maintaining exceptional quality standards.

Roles and Responsibilities Summary: Leadership & Team Management: Directed QA resources, fostering collaboration and efficiency within the team. Continuous Improvement: Identified and implemented enhancements to streamline QA operations. Documentation & Compliance: Oversaw document control, batch record management, SOP distribution, and Annual Product Review (APR) preparation to maintain GMP compliance. Process & Training: Developed operating instructions, conducted training programs, and maintained training records for team qualifications. Quality Audits: Planned and executed internal audits, identifying CAPA actions to uphold GMP standards. Market Complaints & Change Control: Managed deviations, market complaints, and change controls with robust corrective actions. Warehouse QA: Ensured GMP compliance in warehouse operations, including handling of rejected materials and waste disposal. Trend Analysis: Monitored QC and microbiological trends, setting alert limits for water systems and particulate matter. Validation & Calibration: Reviewed validation protocols for sterile and non-sterile systems, including HVAC, water treatment, and aseptic filling processes. IT & Lab Validation: Oversaw equipment validation and IT protocols to maintain system integrity. Aseptic Practices: Led process validation and closure integrity testing to ensure sterile product safety.

Roles and Responsibilities: • Blend & Product Analysis: Conducted comprehensive analysis of blends, bulk, semi-finished, and finished products, ensuring compliance with quality standards. • Raw Material Analysis: Performed rigorous analysis of raw materials to guarantee quality and consistency in production. • Analytical Method Development: Developed and validated analytical methods for the testing and quality control of pharmaceutical products. • Stability Studies: Implemented and monitored accelerated and ongoing stability studies to assess the shelf life and efficacy of products. • Validation Reporting: Prepared detailed reports for validation purposes, supporting regulatory submissions and quality assurance processes. • Training & Knowledge Sharing: Conducted training sessions and seminars on various topics, enhancing the skills and knowledge of the team. • Lab Record Oversight: Ensured compliance with SOPs by reviewing lab records and logbooks maintained by chemists, ensuring accuracy and adherence to protocols.

Roles and Responsibilities: • Sterile Liquid & Vial Filling: Operated equipment for the filling of liquid vials, ampoules, and powder vials, ensuring compliance with sterile manufacturing standards. • Manufacturing of Sterile Products: Contributed to the production of sterile liquid products, maintaining strict adherence to GMP protocols. • Final Packing & Labeling: Managed the final packing and labeling processes, ensuring accuracy and quality. • Employee Training: Trained new employees on sterile area operations, GMP standards, and safety protocols.