Clinical Quality Assurance Specialist

2 days ago

Amrāvati, Maharashtra, India beBeeQuality Full time ₹ 15,00,000 - ₹ 21,00,000
Job Title: Clinical Quality Assurance Specialist

The Clinical Quality Assurance Specialist will play a pivotal role in ensuring the highest standards of quality are met across ongoing clinical trials. This individual will serve as the primary QA support resource for clinical study teams, providing expertise in Good Clinical Practice (GCP) and internal quality standards.

Key Responsibilities:
  1. Serve as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards.
  2. Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, study operations, and trial oversight meetings.
  3. Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
  4. Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
  5. Address QA-related questions from study teams in real-time, providing clear and actionable guidance.
  6. Support inspection readiness and contribute to continuous improvement of QA systems and processes.

Required Skills and Qualifications:
  • Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
  • 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.

Benefits:This is a full-time contract role 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.

About Us: Our organization values quality and commitment to excellence. We are seeking an experienced Clinical Quality Assurance Specialist to join our team.

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