Senior Clinical Quality Assurance Specialist

2 weeks ago

Chennai, Tamil Nadu, India beBeeQuality Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

Clinical Quality Assurance Expert

Job Description:

This is a senior role responsible for overseeing quality compliance in clinical trials. The successful candidate will ensure that all study-related activities, processes, and procedures adhere to applicable regulations and guidelines, maintaining 24x7 inspection/audit readiness.

Key Responsibilities:

  • Establish procedures and trainings to protect human subjects from research risk, maintain data integrity, and ensure internal consistency and quality compliance.
  • Develop and implement a risk-based approach to quality compliance within the function.
  • Prepare and review SOPs related to QC functions, including clinical trial medical science activities and operations.
  • Conduct quality reviews of clinical trial medical science activities, protocols, and SOPs, adhering to ICH GCP requirements.

Requirements:

  • 5+ years of experience in a CRO/Pharma/Biotech organization with a strong background in quality assurance.
  • Excellent analytical and problem-solving skills, with attention to detail and ability to spot inconsistencies.
  • Proven track record of success in handling audits & inspections, with thorough knowledge of recent GCP guidelines and regulatory requirements.

Preferred Qualifications:

  • Experience working in matrix business environments.
  • Strong leadership and conflict management skills.

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