Clinical Trials Quality Assurance Specialist

4 days ago


Kolkata, West Bengal, India beBeeQuality Full time ₹ 8,00,000 - ₹ 14,00,000
Quality Assurance Expert Job Overview

We are seeking a skilled Quality Assurance (QA) professional to provide daily clinical quality assurance support across ongoing clinical trials. The ideal candidate brings strong experience with Veeva QMS and can support clinical operations teams in a fast-paced, remote environment.

Main Responsibilities:
  • Ensure compliance with Good Clinical Practice (GCP) and internal quality standards.
  • Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings.
  • 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.
Qualifications and Skills:
  • Education: Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
  • Experience:
  • 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
  • Prior experience supporting clinical study teams in a QA capacity.
  • Hands-on experience with Veeva QMS.
  • Technical Skills:
  • Proficient in MS Office (Excel, PowerPoint, Word).
  • Skilled in technical writing, SOP drafting, and document formatting.
  • Soft Skills:
  • Excellent communication and interpersonal skills.
  • Strong organizational skills with the ability to work independently.


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