GCP Auditor 21

Profile: An extremely motivated, result-oriented professional with over 19 years of experience in the Clinical Research Arena Rich understanding of ICH guidelines, GCP and global clinical trial requirements leading to successful product registrations across the globe. Highly regarded trainer, mentor for developing and implementing continuous training programs for clinical research staff for their professional development, GCP and regulatory knowledge. Hands-on experience in project management leading to timely completion of clinical studies within defined budget and scope with required quality and ethical standards. Thorough understanding of business development and organizational directives including budget development, interfacing with legal departments, contract negotiations, invoicing and reconciling. Knowledge of the regulatory requirements and successful regulatory inspection experience including US FDA, EMA, UK MHRA, TGA, WHO, ANVISA, MCC South Africa, MOH Malaysia, Turkey, Sudan and CDSCO Development of quality improvement strategies, corrective and preventive action plans and facilitates resolution of audit findings. Skilled in Medical Writing, Statistics, formulating SOPs & quality policies, designing systems and work instructions for conducting Pharmacokinetic & Pharmacodynamic (phase I to late phase) studies. Language Expertise: Marathi, Hindi & English. Based in Mumbai. Can audit in any country.