Experienced Quality Assurance Specialist

4 days ago

Alwar, Rajasthan, India beBeeQuality Full time ₹ 90,00,000 - ₹ 1,20,00,000

Position Overview

We are seeking an experienced Quality Assurance Professional to provide ongoing support for clinical quality assurance across various studies. This role will play a key part in guiding study teams, maintaining adherence to Good Clinical Practice (GCP), and ensuring quality oversight.

Main Responsibilities:

  • Provide day-to-day QA support for clinical study teams, ensuring compliance with GCP and internal quality standards.
  • Offer 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 (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation.

Required Skills and Qualifications:

  • Bachelor's degree in life sciences, healthcare, or a related field (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:

This is a full-time contract position offering 30-40 hours per week of consistent work. The contractor 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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