Clinical Trial Quality Assurance Professional

6 days ago


Alleppey, Kerala, India beBeeClinical Full time ₹ 8,00,000 - ₹ 11,20,000
Quality Assurance Specialist - Clinical Trials

We are seeking a skilled Quality Assurance Specialist to provide day-to-day clinical quality assurance support across ongoing clinical trials.

  • The ideal candidate brings strong experience with Veeva QMS, is highly tech-savvy, and can support clinical operations teams in a fast-paced environment.
  • Serves as the primary QA support resource for clinical study teams, ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.
  • Provides QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings.
Key Responsibilities:
  • Documentation Management: Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
  • Veeva QMS Management: Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
  • QA Support: Address QA-related questions from study teams in real time, providing clear and actionable guidance.
Qualifications:
  • 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 clinical study teams in a QA capacity.
  • Hands-on experience with Veeva QMS.


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