Nilofar Bagban

Background

About Nilofar Bagban

With over 15 years of experience, I am a results-oriented professional specializing in managing Quality Control Microbiology and Sample Management sections. I have a solid background in digitalization projects, including EM-MODA, LIMS, SAP ERP, and Oracle systems. I have extensive experience in establishing greenfield projects for QC microbiology laboratories that meet various regulatory requirements, including those from the EMA, US FDA, and MHRA. My expertise encompasses managing functions related to microbiology, sample management, laboratory practices, and documentation within sterile injectable facilities. My area of expertise is analytical method validation and development in microbiology. I have successfully conducted internal, regulatory, and customer audits, ensuring compliance with the US FDA, Health Canada, EU GMP, GCC, SFDA, ANVISA, WHO, QP, and many other regulatory authorities worldwide. As an effective communicator, I excel in team-building and relationship-building skills, along with strong problem-solving abilities and a detail-oriented approach. I am adept at troubleshooting and adapting to new challenges. My core competencies include maintaining compliance with regulatory requirements through the development of associated laboratory operation policies. I am skilled in analyzing records, reports, practices, and documentation. I have a strong focus on Quality Management Systems, which includes Change Control, Deviation Management, Corrective and Preventive Actions (CAPA), Investigations (Out of Specification, Out of Trend, and Out of Limit), Root Cause Analysis (RCA), Impact Assessment, CAPA effectiveness checks, and Quality Risk Management (QRM). Additionally, I specialize in sterility assurance, contamination control, training and development, continuous quality improvement, process improvement, operational excellence, and the establishment and development of new laboratories. I also have experience in managing outsourced testing, such as cell bank characterization and overseeing method transfers to external Qualified Persons (QP) labs.