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Senior Quality Assurance Professional

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Kottayam, Kerala, India beBeeQuality Full time ₹ 15,00,000 - ₹ 22,50,000

Job Opportunity:

We are currently seeking a skilled professional to fill the position of Quality Assurance Specialist. The ideal candidate will possess strong expertise in quality assurance principles and practices, with a focus on ensuring compliance with Good Clinical Practice (GCP) guidelines.

The selected individual will play a crucial role in supporting clinical study teams by providing high-quality QA services. This includes conducting risk-based quality management activities, reviewing and updating standard operating procedures (SOPs), and managing quality processes within Veeva QMS.

Key Responsibilities:

  • Serve as primary QA support resource for clinical study teams, ensuring adherence to GCP and internal quality standards.
  • Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, study operations, and trial oversight meetings.
  • Write, review, update, and format SOPs and other quality documentation.
  • Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
  • Support inspection readiness and contribute to continuous improvement of QA systems and processes.

Requirements:

  • Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
  • At least 5 years of experience in clinical quality assurance with a strong foundation in GCP.
  • Prior experience supporting clinical study teams in a QA capacity.
  • Hands-on experience with Veeva QMS.

Benefits:

  • Opportunity to work with experienced professionals in the field.
  • Challenging role that requires strong analytical and problem-solving skills.
  • Ongoing training and development opportunities.