Senior Clinical Quality Assurance Specialist

4 days ago


Thiruvananthapuram, Kerala, India beBeeQuality Full time ₹ 2,50,000 - ₹ 5,00,000

Key Role: Clinical Quality Assurance (QA) Support

  • Ensure compliance with Good Clinical Practice (GCP) and internal quality standards as primary QA support for clinical study teams.
  • Lead protocol deviation meetings, risk-based quality management discussions, study operations, and trial oversight meetings.
  • Develop and maintain standard operating procedures (SOPs) and quality documentation.
  • Manage quality processes within a quality management system (QMS), including document control, training, and corrective action and preventive action (CAPA) management.
  • Collaborate with cross-functional stakeholders to ensure quality expectations and risk mitigation.

Essential Qualifications:

  • Bachelor's degree in life sciences, healthcare, or a related field.
  • 5+ years of clinical quality assurance experience with a strong GCP foundation.
  • Prior experience supporting clinical study teams in a QA capacity.
  • Hands-on experience with a QMS and technical writing skills.

Preferred Qualifications:

  • Advanced degree in a relevant field.
  • Additional certifications or training in clinical quality assurance or regulatory affairs.

Benefits:

  • Full-time contract role offering consistent work hours.
  • Opportunity to act as a core member of the QA function, providing essential support to ongoing clinical programs.

Working Hours:

  • Must be available during Eastern or Mountain Time Zone working hours to attend study calls and provide timely QA support.


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