Clinical Quality Assurance Compliance Specialist

23 hours ago


Nagpur, Maharashtra, India beBeeCompliance Full time ₹ 17,00,000 - ₹ 23,00,000
Clinical Quality Assurance Compliance Specialist

This role is responsible for overseeing clinical trial activities from a quality perspective, ensuring adherence to applicable regulations and guidelines. Key responsibilities include reviewing study-related activities, processes, and procedures; developing and implementing risk-based approaches to quality compliance; and preparing SOPs related to QC functions.

Key Responsibilities:
  • Quality review of clinical trial medical science activities
  • Development and implementation of risk-based approaches to quality compliance
  • Preparation of SOPs related to QC functions

Required Skills and Qualifications:

  • 5+ years of experience in a CRO/Pharma/Biotech organization with Quality department experience
  • Strong attention to detail and conflict management skills
  • Experience handling audits and inspections (DCGI, US FDA)
  • Thorough knowledge of GCP guidelines and other applicable regulations

Benefits:

This role offers the opportunity to work in a matrix business environment and contribute to the success of our organization through effective quality assurance practices.



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