Clinical Quality Assurance Compliance Expert

1 day ago


Kannur, Kerala, India beBeeQualityCompliance Full time ₹ 18,00,000 - ₹ 25,20,000

Job Title: Clinical Quality Assurance Compliance Specialist

Description:

The Clinical Quality Assurance Compliance Specialist will oversee clinical trial activities from a quality perspective, ensuring adherence to applicable regulations and guidelines. This role will be responsible for establishing procedures and trainings to protect human subjects, ensure data reliability/integrity, and maintain internal consistency and quality compliance measures.

The successful candidate will have 5 years of experience in a CRO/Pharma/Biotech organization, with a strong eye for detail and ability to spot inconsistencies. They will also have experience handling audits & inspections of DCGI, US FDA, and thorough knowledge of recent GCP guidelines, ICMR guidelines, and Drugs and Cosmetic Act regulations.

Responsibilities include:

  • Oversight on end-to-end clinical trial activities
  • Review of study-related activities, processes, and procedures
  • Establishing procedures and trainings for teams
  • Developing and implementing a risk-based approach to Quality Compliance
  • Preparation and review of SOPs related to QC function

Requirements:

  • 5 years' experience in Quality department with Quality activities in Clinical Research department
  • Strong eye for detail and conflict management skills
  • Experience handling audits & inspections of DCGI, US FDA
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, and Drugs and Cosmetic Act regulations

Benefits:

  • Opportunity to work in a dynamic matrix business environment
  • Chance to develop and implement innovative Quality Compliance approaches


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