Clinical Quality Assurance Specialist

14 hours ago

Hubli, Karnataka, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Clinical Quality Assurance Compliance Job

We are seeking a highly skilled and experienced individual to fill the role of Clinical Quality Assurance Compliance. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and clinical research.

Job Description:

This role will be responsible for ensuring that all clinical trial activities are conducted in accordance with applicable regulations and guidelines. This includes reviewing and approving study-related documents, conducting site visits, and ensuring that all team members are trained on relevant SOPs.

Key Responsibilities:

  • Oversight of end-to-end clinical trial activities from a quality perspective.
  • Review of all study-related activities, processes, procedures, and adherence to applicable regulations and guidelines.
  • Establishing procedures and trainings of teams to ensure protection of human subjects from research risk and reliability/integrity of data.
  • Developing and implementing a risk-based approach to quality compliance within the function.

Required Skills and Qualifications:

  • 5+ years of experience in a CRO/Pharma/Biotech organization in quality department.
  • Strong eye for detail and ability to spot inconsistencies.
  • Good conflict management skills.
  • Experience in handling audits & inspections of DCGI, US FDA.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials.

Benefits:

This role offers a challenging and rewarding opportunity for a motivated individual to make a meaningful contribution to the success of our organization.

How to Apply:

Interested candidates should submit their resume and cover letter for consideration.

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