Senior Quality Assurance Specialist

4 days ago

Ellore, Andhra Pradesh, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: Clinical Quality Assurance Compliance

Overview

We are seeking a highly skilled and experienced professional to lead our clinical quality assurance compliance efforts. This role will be responsible for overseeing end-to-end clinical trial activities from a quality perspective, ensuring adherence to applicable regulations and guidelines.

Key Responsibilities

  • Oversight of quality compliance activities across various teams, including Clinical Trial Medical Science, Operations, and Data Management.
  • Establishing procedures and trainings to ensure protection of human subjects, data integrity, and internal consistency.
  • Developing and implementing a risk-based approach to quality compliance within the function.
  • Preparation and review of SOPs related to quality compliance activities.

Requirements

  • 5+ years' experience in a CRO/Pharma/Biotech organization with a strong focus on quality activities in clinical research departments.
  • Strong eye for detail and ability to spot inconsistencies.
  • Experience handling audits & inspections, with a proven track record of success.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, and other applicable regulations pertaining to clinical trials.

Bonus Points

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

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