Clinical Quality Assurance Specialist

3 days ago

Tirupati, Andhra Pradesh, India beBeeQuality Full time ₹ 10,00,000 - ₹ 13,00,000

We are seeking an experienced QA Professional to provide day-to-day clinical quality assurance support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP), and ensuring quality oversight.

The ideal candidate brings strong experience with Veeva QMS, is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment.

Key Responsibilities
  • Serve as the primary QA support resource for clinical study teams, ensuring compliance with 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 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.
  • Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation.

To be successful in this role, you must have excellent communication and interpersonal skills, strong organizational skills, and the ability to work independently.

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 QA 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.

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