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Clinical Assurance Coordinator

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Malappuram, Kerala, India beBeeQuality Full time ₹ 12,00,000 - ₹ 15,00,000

Job Title: QA Specialist

Key Responsibilities:
  • Serve as the primary quality assurance support resource for clinical study teams, ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.
  • Provide quality assurance expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, 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 quality-related questions from study teams in real time, providing clear and actionable guidance.
  • Support inspection readiness and contribute to continuous improvement of quality systems and processes.
  • Partner with cross-functional stakeholders to align on quality expectations and risk mitigation.
Qualifications:
  • 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 quality 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.

This is a full-time contract role offering consistent work. The contractor will act as a core member of the quality function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.