Anas Bousairi

WORK HISTORY

EDUCATION

ABOUT ANAS BOUSAIRI

With over 10 years of experience in the pharmaceutical, radiopharmaceutical, and biomedical sectors,I have had the privilege of working in the pharmaceutical, radiopharmaceutical, and biomedical sectors, collaborating with various departments to consistently achieve business success. I specialize in commissioning and qualification, leading engineering activities focused on compliance with Good Documentation Practices (GDP), based on the ALCOA attributes (Attributable, Legible, Contemporary, Original, Accurate). I am experienced in engineering quality processes according to ICH Q10, change management, and utilizing traceability matrices to verify points defined in User Requirements Specifications (URS), Critical Attributes (CAs), and Critical Design Elements (CDEs). Additionally, I possess strong knowledge of GMP and industry standards in quality and engineering within the pharmaceutical industry.I have gained hands-on experience with diverse equipment, including HVAC systems, cleanrooms, isolators, reactors, bioreactors, autoclaves, refrigerators, incubators, environmental monitoring systems, laboratory instruments, and utilities (e.g, nitrogen, PWI, PCA, steam, chilled water), centrifuges, filter dryers, chillers, and compressors.Additionally, I have worked in metrology and quality departments, at both operational and managerial levels. I oversee new projects, inspections, and suppliers, excelling in problem-solving and consistently delivering results. I have a proven track record in developing and implementing strategies for continuous improvement in engineering and quality processes. My goal is to cultivate a culture of innovation and development, empowering companies to achieve their objectives.Core Competencies:• Technical Analysis: Assessing and resolving technical challenges.• Metrology Laboratory Management: Optimizing laboratory operations.• Environmental Controls: Managing monitoring and control systems.• Validation: Validating equipment, systems, and processes.• Team Collaboration & Leadership: Building effective teams.• Project & Team Management: Leading projects from start to finish.• Commissioning & Qualification Leadership: Leading CQV activities to ensure compliance.• Validation Documentation & GMP Standards: Expertise in preparing validation documentation.• Engineering Expertise: In-depth knowledge of engineering systems.• Quality Assurance: Ensuring quality across production.• HVAC/AHU/Black Utilities CQV: Specialized in CQV for HVAC, AHU, and critical utilities.