Quality Assurance Consultant

6 days ago

Kanpur, Uttar Pradesh, India beBeeQuality Full time US$ 80,000 - US$ 1,25,000

Job Title: Quality Assurance Specialist

About the Position

We are seeking a seasoned Quality Assurance (QA) professional to provide ongoing clinical quality assurance support across multiple clinical trials. This role will play a key part in guiding study teams, ensuring compliance with Good Clinical Practice (GCP), and delivering quality oversight.

Main Responsibilities:
  • Serve as the primary QA resource for clinical study teams, guaranteeing adherence to GCP and internal quality standards.
  • Offer 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, encompassing 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.
Key Requirements:
  • Education: Bachelor's degree in life sciences, healthcare, or a related field (advanced degree preferred).
  • Experience:
  • A minimum of 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.

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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