Senior QA Professional

2 days ago

Nellore, Andhra Pradesh, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000
Quality Assurance Expert

This role is crucial in directing study teams, ensuring compliance with Good Clinical Practice (GCP), and overseeing quality standards.

The ideal candidate possesses 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 resource for clinical study teams, guaranteeing adherence to GCP and internal quality standards.
  • Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight 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.
Required Skills and 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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