Imran Khan

WORK HISTORY

EDUCATION

ABOUT IMRAN KHAN

Over 8+ years of global quality assurance/ regulatory affairs experience in the Pharmaceutical Industry. Knowledge of Drug development through commercialization, electronic submissions IND and NDA, ANDA, 510(K), PMA (Pre-Market Approval) regulations to FDA, CTA & MAA submissions to EMA. My technical expertise covers many areas of product/process development, validation, and quality assurance including – life cycle management of products and processes, root cause analysis, formulating corrective and preventive actions, change control management, technology transfer, equipment qualification, validation of cleaning, and manufacturing processes. I am also proficient in analyzing, evaluating, trending, reporting quality, technical data, and regulatory submission documentation. I can work independently or in a team on projects of any magnitude or complexity. I can lead teams and collaborate with multi-functional teams in planning and managing projects. I am actively seeking Full-Time opportunities in the Regulatory Affairs/Quality Assurance Department in the United States. Key Skills: Regulatory Affairs Quality Assurance Validation ( Cleaning Validation; Process Validation; Technology Transfer ) and Qualification Incident and Deviation Handling Root Cause Analysis Change Control Risk Assessment Gap Analysis Audits and Inspections Quality Risk Management Training