Principal Quality Assurance Specialist

6 days ago

Kannur, Kerala, India beBeeQuality Full time ₹ 14,00,000 - ₹ 14,90,000

Our organization seeks a Quality Assurance Professional to deliver day-to-day clinical quality assurance support across ongoing clinical trials. This role will play a pivotal part in guiding study teams and ensuring compliance with Good Clinical Practice (GCP).

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

  • Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and 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.

Key Responsibilities

  • Serve as the primary QA support resource for clinical study teams.
  • Ensure compliance with GCP and internal quality standards.

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.
  • Soft Skills:
  • Excellent communication and interpersonal skills.
  • Strong organizational skills with the ability to work independently.

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