Clinical Quality Assurance Lead

4 days ago

Kannur, Kerala, India beBeeQuality Full time ₹ 11,25,000 - ₹ 14,25,000

Job Overview

We are seeking a skilled Clinical Quality Assurance Specialist to play a crucial role in guiding study teams and ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.

This is a key member position within our QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.

The ideal candidate will have 5+ years of Clinical Quality Assurance experience, a strong foundation in GCP, and hands-on experience with Veeva QMS.

Responsibilities
  • Serve as the primary QA support resource for clinical study teams, providing guidance on GCP and internal quality standards.
  • Lead protocol deviation meetings, risk-based quality management discussions, study operations, and trial oversight meetings during study calls.
  • Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
  • Manage and track quality processes, including document control, training, and CAPA management in Veeva QMS.
  • 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.
Requirements

To succeed in this role, you must possess excellent communication and interpersonal skills, be proficient in MS Office and technical writing, and work independently with minimal supervision.

A bachelor's degree in a relevant field is required. A Master's degree or higher is preferred.

Working Arrangements

This is a full-time contract role offering consistent work hours of 30–40 hours per week. The position requires flexibility and adaptability to meet the needs of the study teams and organization.

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