Clinical Operations Quality Lead

1 day ago

Bhavnagar, Gujarat, India beBeeQuality Full time ₹ 12,00,000 - ₹ 14,00,000
Quality Assurance Specialist Role

The Quality Assurance (QA) Specialist role is a vital component of our clinical operations team. We are seeking an experienced and skilled professional to provide day-to-day QA support across ongoing clinical trials.

This position requires strong experience with quality assurance principles, technical skills, and the ability to work effectively in a fast-paced environment. The ideal candidate will bring a high level of expertise in Veeva QMS and be able to support clinical operations teams in achieving regulatory compliance.

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 meetings.
  • Develop, 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.
  • Collaborate with cross-functional stakeholders to align on quality expectations and risk mitigation.

The successful candidate will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.

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