Fahima Shabon

•Highly motivated and experienced Validation Scientist/Engineer with 7 years of experience in Pharmaceutical Industry. •Articulate and highly analytical Bachelor of Science in Micro-Biology graduate equipped with outstanding communication and technical writing skills; combined with hands-on experience in conducting Container Closure Integrity Validation studies in support of projects. •Proficient in prioritizing and completing tasks in a timely manner, yet flexible to multitask when necessary. •Knowledge of Quality Assurance and Quality Control methodology and procedures •Follow and comply with GMP, GLP and FDA guidance •Experience reviewing and evaluating Validation Protocols, Technical Protocols, Developmental Protocols and their applicable SOP’s. •Strong knowledge of documentation practices and aseptic technique along with good grasp of mechanical concepts related to pharmaceutical equipment •In-depth knowledge of study processes and procedures related to functional areas and FDA regulations •Capable of building cohesive work environments, initiating improvement procedures, and streamlining Validation functions to achieve goals and align plans toward scientific excellence. •Systematic and organized, competent at writing Validation protocols, Final reports and executing test protocols. •Known for taking initiative and skilled at meeting challenges and deadlines. A team player who is attentive to detail and produces quality results. •A quick learner with a desire for continuous personal growth. •Very experienced in working with different mammalian culture/expression systems. Thorough understanding of cell expansion and viral propagation •Excellent problem solving and troubleshooting skills •Proficient with GLP and GMP.