Clinical Quality Assurance Professional

3 days ago


Vellore, Tamil Nadu, India beBeeQuality Full time ₹ 60,00,000 - ₹ 1,20,00,000

We are seeking a seasoned Clinical Quality Assurance professional to provide day-to-day support across ongoing clinical trials.

The ideal candidate brings strong experience with Veeva QMS, is highly tech-savvy, and can collaborate with clinical operations teams in a fast-paced, remote environment.

Key Responsibilities:

  • Serve as the primary QA resource for clinical study teams, ensuring 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.
  • Develop and maintain 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.
  • Collaborate 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 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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