QA Expert

2 days ago


Ahmedabad, Gujarat, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000

Job Overview

We are seeking a seasoned professional to provide clinical quality assurance support across ongoing clinical trials.

  • Primary Responsibilities:
  • Serve as the primary QA resource for study teams, ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.
  • Provide QA expertise during calls, including protocol deviation meetings, risk-based quality management discussions, operations and trial oversight meetings, and write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
  • Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
  • Address QA-related questions from study teams in real time, providing clear and actionable guidance.
  • Support inspection readiness and contribute to continuous improvement of QA systems and processes.
  • Partner with cross-functional stakeholders to align on quality expectations and risk mitigation.

Requirements

  • Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
  • 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
  • Prior experience supporting study teams in a QA capacity.
  • Hands-on experience with Veeva QMS.

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