Clinical Quality Auditor

2 days ago

Bengaluru, Karnataka, India beBeeClinicalQuality Full time ₹ 13,53,600 - ₹ 20,35,680
Clinical Quality Assurance Professional

We are seeking a skilled Clinical Quality Assurance (CQA) professional to join our team. As a CQA, you will be responsible for ensuring that our clinical studies are conducted in compliance with regulatory guidelines and internal SOPs.

Key Responsibilities:

  • Perform in-process audits at various stages based on study design and risk.
  • Perform retrospective audits of clinical study documents against the study protocol, internal SOPs, and applicable regulatory guidelines.
  • Prepare and issue audit reports to the operations team in consultation with the Manager and Department Head.
  • Review change control, deviation, and other QMS elements taken by the operations team and follow up for timely closure.
  • Review draft documents such as protocols, ICDs, CRFs, etc., before finalization.

Requirements:

  • 6-9 years of experience in auditing, with demonstrated capability in auditing skills, understanding of regulations, and attention to detail.
  • M.Sc or M.Pharm degree.

Benefits:

This role offers a unique opportunity to work in a dynamic environment, contributing to the development of procedures, practices, and systems that ensure safe operations and compliance to company integrity, quality standards.

Syngene Values:

All employees will consistently demonstrate alignment with our core values: Excellence, Integrity, and Professionalism.

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