Clinical Quality Assurance Lead

1 day ago

Lucknow, Uttar Pradesh, India beBeeQuality Full time ₹ 7,50,000 - ₹ 10,00,000
Key Responsibilities for QA Specialist

The primary function of this role is to provide day-to-day clinical quality assurance support across ongoing clinical trials. This involves ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.

  • A key responsibility will be serving as the primary QA support resource for clinical study teams, providing guidance on quality management discussions and protocol deviation meetings.
  • QA expertise will also be provided during study calls, including risk-based quality management discussions and trial oversight meetings.
  • The ideal candidate will be able to write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
  • Additionally, the individual will manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
  • Support will also be given to address QA-related questions from study teams in real time, providing clear and actionable guidance.
  • Inspection readiness will be supported, and the individual will contribute to continuous improvement of QA systems and processes.
  • Cross-functional collaboration will be required with stakeholders such as Clinical Operations, Data Management, and Regulatory teams to align on quality expectations and risk mitigation.

Requirements and Skills

  1. Extensive experience in clinical quality assurance is essential, with a strong background in Veeva QMS.
  2. Strong communication and technical skills are necessary to effectively collaborate with cross-functional teams and provide quality support.
  3. Highly organized and detail-oriented, the ideal candidate must be able to prioritize tasks and manage multiple projects simultaneously.
  4. Ability to work independently and as part of a team is crucial, with a focus on delivering high-quality results and meeting deadlines.

Benefits

This role offers a dynamic and challenging environment where individuals can grow professionally and develop their skills. As a member of our team, you will have opportunities to learn and improve your knowledge and expertise, contributing to the success of our organization.

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